71209-083 : Labetalol Hydrochloride 100 mg Oral Tablet, Film Coated


NDC: 71209-083
Labeler: Cadila Pharmaceuticals Limited
Product Type: Human Prescription Drug
Drug Name:  Labetalol Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA211325
Rev. Date: 


Appearance:


Markings: C82
Shapes:  Round
Colors:  White
Size (mm): 8
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 71209-083-03: 60 TABLET, FILM COATED IN 1 BOTTLE (71209‑083‑03)
  • 71209-083-05: 100 TABLET, FILM COATED IN 1 BOTTLE (71209‑083‑05)
  • 71209-083-10: 500 TABLET, FILM COATED IN 1 BOTTLE (71209‑083‑10)
  • 71209-083-11: 1000 TABLET, FILM COATED IN 1 BOTTLE (71209‑083‑11)

Active Ingredients:

  • Labetalol Hydrochloride

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Starch, Corn
  • Hypromellose 2910 (5 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polysorbate 80
  • Sodium Starch Glycolate Type a Potato
  • Hypromelloses
  • Polyethylene Glycol 6000
  • Titanium Dioxide
  • Talc /

Pharmaceutical Classes:

  • Adrenergic beta-Antagonists [MoA]
  • beta-Adrenergic Blocker [EPC]

Related Products:

Based on records with the same trade name.
  • 71209-084 Labetalol Hydrochloride 200 mg Oral Tablet, Film Coated by Cadila Pharmaceuticals Limited
  • 71209-085 Labetalol Hydrochloride 300 mg Oral Tablet, Film Coated by Cadila Pharmaceuticals Limited
  • 0143-9320 Labetalol Hydrochloride 5 mg/ml Intravenous Injection by West-ward Pharmaceuticals Corp
  • 0143-9622 Labetalol Hydrochloride 5 mg/ml Intravenous Injection by West-ward Pharmaceuticals Corp
  • 0143-9623 Labetalol Hydrochloride 5 mg/ml Intravenous Injection by West-ward Pharmaceuticals Corp
  • 0172-4364 Labetalol Hydrochloride 100 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-4365 Labetalol Hydrochloride 200 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0172-4366 Labetalol Hydrochloride 300 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0409-0125 Labetalol Hydrochloride 5 mg/ml Intravenous Injection, Solution by Hospira, Inc.
  • 0409-2267 Labetalol Hydrochloride 5 mg/ml Intravenous Injection, Solution by Hospira, Inc.
  • 0409-2339 Labetalol Hydrochloride 5 mg/ml Intravenous Injection, Solution by Hospira, Inc.
  • 0591-0605 Labetalol Hydrochloride 100 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0606 Labetalol Hydrochloride 200 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0607 Labetalol Hydrochloride 300 mg Oral Tablet by Watson Laboratories, Inc.
  • 0615-4539 Labetalol Hydrochloride 200 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-7686 Labetalol Hydrochloride 100 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-7687 Labetalol Hydrochloride 200 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-7688 Labetalol Hydrochloride 300 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-8512 Labetalol Hydrochloride 100 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, LLC Dba Vangard Labs
  • 0615-8513 Labetalol Hydrochloride 200 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, LLC Dba Vangard Labs
  • More related products ...

NDC QR Code

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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.