42549-543 : Promethazine Hydrochloride 25 mg Oral Tablet


NDC42549-543
Labeler: Stat Rx USA LLC
Product Type: Human Prescription Drug
Drug Name:  Promethazine Hydrochloride
Dosage Form: Oral Tablet
Application #: ANDA083426
Rev. Date: 


Appearance:


Markings: DAN;DAN;5307
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.

DAN DAN 5307: (0591-5307) Promethazine Hydrochloride 25 mg Oral Tablet by Stat Rx USA LLC
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:

  • 42549-543-10: 10 TABLET IN 1 BOTTLE (42549‑543‑10)
  • 42549-543-20: 20 TABLET IN 1 BOTTLE (42549‑543‑20)
  • 42549-543-30: 30 TABLET IN 1 BOTTLE (42549‑543‑30)

Active Ingredients:

  • Promethazine Hydrochloride

Dosage Strength:

  • 25 mg

Inactive Ingredients:

  • Dibasic Calcium Phosphate Dihydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid

Pharmaceutical Classes:

  • Phenothiazine [EPC]
  • Phenothiazines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 16590-047 Promethazine Hydrochloride 12.5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-191 Promethazine Hydrochloride 25 mg Oral Tablet by Stat Rx USA LLC
  • 0115-1040 Promethazine Hydrochloride 12.5 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1041 Promethazine Hydrochloride 25 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1042 Promethazine Hydrochloride 50 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0121-0927 Promethazine Hydrochloride 6.25 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
  • 0143-9868 Promethazine Hydrochloride 50 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp
  • 0143-9869 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp
  • 0378-7028 Promethazine Hydrochloride 12.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7029 Promethazine Hydrochloride 25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-7030 Promethazine Hydrochloride 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0404-9940 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
  • 0404-9941 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
  • 0404-9942 Promethazine Hydrochloride 50 mg/ml Intramuscular Injection by Henry Schein, Inc.
  • 0409-2312 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0440-5195 Promethazine Hydrochloride 25 mg Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 0440-8195 Promethazine Hydrochloride 25 mg/1 Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 0591-5307 Promethazine Hydrochloride 25 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-5319 Promethazine Hydrochloride 50 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-1584 Promethazine Hydrochloride 6.25 mg/5ml Oral Syrup by Qualitest Pharmaceuticals
  • More related products ...

NDC QR Code

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NDC 42549-543 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.