33342-058 : Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet


NDC: 33342-058
Labeler: Macleods Pharmaceuticals Limited
Product Type: Human Prescription Drug
Drug Name:  Irbesartan and Hydrochlorothiazide
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA202414
Rev. Date: 


Appearance:


Markings: ML;33
Shapes:  Oval
Colors:  Orange
Size (mm): 17
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

ML 33: (33342-058) Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Macleods Pharmaceuticals Limited
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 33342-058-06: 3 BLISTER PACK IN 1 CARTON (33342‑058‑06) > 10 TABLET, FILM COATED IN 1 BLISTER PACK
  • 33342-058-07: 30 TABLET, FILM COATED IN 1 BOTTLE (33342‑058‑07)
  • 33342-058-10: 90 TABLET, FILM COATED IN 1 BOTTLE (33342‑058‑10)
  • 33342-058-15: 500 TABLET, FILM COATED IN 1 BOTTLE (33342‑058‑15)
  • 33342-058-39: 9 BLISTER PACK IN 1 CARTON (33342‑058‑39) > 10 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Irbesartan
  • Hydrochlorothiazide

Dosage Strength:

  • 300 mg
  • 12.5 mg

Inactive Ingredients:

  • Carboxymethylcellulose Calcium
  • Silicon Dioxide
  • Povidone K29/32
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Magnesium Stearate
  • Hypromellose 2910 (15 Mpa.s)
  • Titanium Dioxide
  • Polyethylene Glycol 3000
  • Lactose Monohydrate
  • Ferric Oxide Yellow
  • Ferric Oxide Red

Pharmaceutical Classes:

  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]
  • Increased Diuresis [PE]
  • Thiazide Diuretic [EPC]
  • Thiazides [CS]

Related Products:

Based on records with the same trade name.
  • 33342-057 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Macleods Pharmaceuticals Limited
  • 0054-0254 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0054-0255 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Roxane Laboratories, Inc.
  • 0093-7238 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-7239 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8232 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-8238 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0378-3033 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-3034 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0591-2785 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2786 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-4088 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-4089 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0955-1045 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Winthrop U.S.
  • 0955-1046 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Winthrop U.S.
  • 29300-215 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-216 Irbesartan and Hydrochlorothiazide Oral Tablet, Film Coated by Unichem Pharmaceuticals (Usa), Inc.
  • 42291-340 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Avkare, Inc.
  • 42291-341 Hctz 12.5 mg / Irbesartan 300 mg Oral Tablet by Avkare, Inc.
  • 42291-342 Hctz 12.5 mg / Irbesartan 150 mg Oral Tablet by Avkare, Inc.
  • More related products ...

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 33342-058 QR Code

< Prev: 33342-057Next: 33342-060 >

Related Discussions:

Hydrochlorothiazide 12 5 Mg Side Effects
how do you take the med???and how late to take not to make you get up during the night???? ## When I was on them, my doc... 9 replies
Hydrochlorothiazide/25mg effects?
What are the effects of this drug? Are there any side effects? ## half the 25 mg prescribed for HBP; need to know about ... 8 replies
Hydrochlorothiazide 25 Mg Side Effects
After after taking hydrochlorothiazide 25mg I HAVE RINGING In ears. Dry mouth, hearing loss. Not sure if this is related... 6 replies
Hydrochlorothiazide And Triamterene By Sandoz Pharmaceuticals
My aunt has been taking the Sandoz Pharmaceutical, hydrochlorothiazide and triamterene for 13 yrs. The GG606, now the ph... 6 replies
HYDROCHLOROTHIAZIDE Missed Dose
If you do not take this medication for 3-5 days can it cause water retention right away? ## Yes,I agree,especially durin... 6 replies
Hydrochlorothiazide 25mg Uses
Is this a water pill or a high blood pressure pill? ## It actually lowers blood pressure by expelling water from the bod... 4 replies
Hydrochlorothiazide 12.5mg Capsule
Need to Verify identification of Capsule: Small White Capsule with imprint Mylan 810 ## Pill Image You are correct, this... 4 replies
hydrochlorothiazide 12 5mg side effects
Prescribed hydrochlorothiazide 12.5mg for hypertension. Took for 1st 3 months with no problems outside of frequent urina... 3 replies
Hydrochlorothiazide Side Effects
I'm taking Hydrochlorothiazide for water retention due to a side effect from high estrogen levels in my birth contro... 3 replies
Hydrochlorothiazide 12 5 Mg
Can dayquil and nitequil be used with this medacation? ## There are no interactions listed between using them, while on ... 3 replies




Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.