NDC 0115-1911

Rimantadine Hydrochloride

Rimantadine Hydrochloride

Rimantadine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Rimantadine Hydrochloride.

• Product ID: 0115-1911_10ac3ab8-78a4-4a5e-a4c1-b2e35fe7d865
• NDC: 0115-1911
• Product Type: Human Prescription Drug
• Proprietary Name: Rimantadine Hydrochloride
• Generic Name: Rimantadine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2021-11-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076132
• Labeler Name: Amneal Pharmaceuticals of New York LLC
• Substance Name: RIMANTADINE HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0115-1911-01

100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)

• Marketing Start Date: 2021-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-1911-01 [00115191101]

Rimantadine Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA076132
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-04-01

NDC 0115-1911-02 [00115191102]

Rimantadine Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA076132
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2005-04-01

Drug Details

Active Ingredients

Ingredient	Strength
RIMANTADINE HYDROCHLORIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 49f7d69a-820b-4c75-a31d-b2104c019c12
• Manufacturer:
  • Impax Generics
• UNII:
  • JEI07OOS8Y
• RxNorm Concept Unique ID - RxCUI:
  • 856605
• UPC Code:
  • 0301151911017

Pharmacological Class

• Influenza A M2 Protein Inhibitor [EPC]
• M2 Protein Inhibitors [MoA]

NDC Crossover Matching brand name "Rimantadine Hydrochloride" or generic name "Rimantadine Hydrochloride"

NDC	Brand Name	Generic Name
0115-1911	Rimantadine Hydrochloride	Rimantadine Hydrochloride
52959-305	Rimantadine Hydrochloride	Rimantadine Hydrochloride
63629-3552	Rimantadine Hydrochloride	Rimantadine Hydrochloride
68151-2103	Rimantadine Hydrochloride	Rimantadine Hydrochloride