54868-6203 : Nitrofurantoin 100 mg (Nitrofurantoin Macrocrystals 25 mg / Nitrofurantoin Monohydrate 75 mg) Oral Capsule


NDC: 54868-6203
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Nitrofurantoin Monohydrate/Macrocrystals
Dosage Form: Oral Capsule
Application #: ANDA076648
Rev. Date: 


Appearance:


Markings: MYLAN;3422
Shapes:  Capsule
Colors:  Gray / Brown
Size (mm): 18
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.

MYLAN 3422: (0378-3422) Nitrofurantoin 100 mg (Nitrofurantoin Macrocrystals 25 mg / Nitrofurantoin Monohydrate 75 mg) Oral Capsule by Physicians Total Care, Inc.
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:

  • 54868-6203-0: 14 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑6203‑0)
  • 54868-6203-1: 20 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑6203‑1)
  • 54868-6203-2: 6 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑6203‑2)
  • 54868-6203-3: 10 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑6203‑3)

Active Ingredients:

  • Nitrofurantoin
  • Nitrofurantoin Monohydrate

Dosage Strength:

  • 25 mg
  • 75 mg

Inactive Ingredients:

  • Alginic Acid
  • Calcium Phosphate, Dibasic, Anhydrous
  • Ferrosoferric Oxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Gelatin
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Propylene Glycol
  • Ferric Oxide Red
  • Shellac
  • Sodium Alginate
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Nitrofuran Antibacterial [EPC]
  • Nitrofurans [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
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  • 0480-3470 Nitrofurantoin (Monohydrate/Macrocrystals) Oral Capsule by Teva Pharmaceuticals USA, Inc.
  • 0591-3658 Nitrofurantoin Monohydrate Macrocrystals Oral Capsule by Actavis Pharma, Inc.
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  • 59746-762 Nitrofurantoin (Monohydrate/Macrocrystals) Oral Capsule by Jubilant Cadista Pharmaceuticals Inc.
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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.