0378-5114 : Hydralazine Hydrochloride 100 mg Oral Tablet


NDC0378-5114
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydralazine Hydrochloride
Dosage Form: Oral Tablet
Application #: ANDA090413
Rev. Date: 


Appearance:


Markings: M;H14
Shapes:  Round
Colors:  Pink
Size (mm): 10
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.

NDC Package Codes:

  • 0378-5114-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑5114‑01)
  • 0378-5114-10: 1000 TABLET IN 1 BOTTLE, PLASTIC (0378‑5114‑10)

Active Ingredients:

  • Hydralazine Hydrochloride

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Sodium Lauryl Sulfate

Pharmaceutical Classes:

  • Arteriolar Vasodilation [PE]
  • Arteriolar Vasodilator [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-5111 Hydralazine Hydrochloride 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5112 Hydralazine Hydrochloride 25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5113 Hydralazine Hydrochloride 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0182-0554 Hydralazine Hydrochloride 25 mg Oral Tablet by Goldline Laboratories, Inc.
  • 0182-0555 Hydralazine Hydrochloride 50 mg Oral Tablet by Goldline Laboratories, Inc.
  • 0182-0905 Hydralazine Hydrochloride 10 mg Oral Tablet by Goldline Laboratories, Inc.
  • 0404-9875 Hydralazine Hydrochloride 20 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
  • 0404-9986 Hydralazine Hydrochloride 20 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
  • 0404-9994 Hydralazine Hydrochloride 20 mg/ml Intramuscular; Intravenous Injection, Solution by Henry Schein, Inc.
  • 0517-0901 Hydralazine Hydrochloride 20 mg/ml Intramuscular; Intravenous Injection, Solution by American Regent, Inc.
  • 0615-0516 Hydralazine Hydrochloride 10 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-0531 Hydralazine Hydrochloride 25 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-0532 Hydralazine Hydrochloride 50 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-5649 Hydralazine Hydrochloride 100 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-7973 Hydralazine Hydrochloride 100 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0641-6231 Hydralazine Hydrochloride 20 mg/ml Intramuscular; Intravenous Injection, Solution by Hikma Pharmaceuticals USA Inc.
  • 0904-6440 Hydralazine Hydrochloride 10 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-6441 Hydralazine Hydrochloride 25 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-6442 Hydralazine Hydrochloride 50 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-6443 Hydralazine Hydrochloride 100 mg Oral Tablet, Film Coated by Major Pharmaceuticals
  • 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.