NDC 65841-755

Galantamine

Galantamine

Galantamine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Galantamine Hydrobromide.

• Product ID: 65841-755_6ef0e163-f218-4693-b490-a4e863220942
• NDC: 65841-755
• Product Type: Human Prescription Drug
• Proprietary Name: Galantamine
• Generic Name: Galantamine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-10-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078898
• Labeler Name: Zydus Lifesciences Limited
• Substance Name: GALANTAMINE HYDROBROMIDE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 65841-755-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-755-01)

• Marketing Start Date: 2011-10-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65841-755-01 [65841075501]

Galantamine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078898
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-10

NDC 65841-755-30 [65841075530]

Galantamine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078898
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-10
• Marketing End Date: 2019-12-03

NDC 65841-755-10 [65841075510]

Galantamine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078898
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-10

NDC 65841-755-14 [65841075514]

Galantamine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078898
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-10

NDC 65841-755-77 [65841075577]

Galantamine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078898
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-10-10

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	4 mg/1

OpenFDA Data

• SPL SET ID: 63bad97b-3df6-4e8f-b183-95f1e9801c8f
• Manufacturer:
  • Cadila Healthcare Limited
• UNII:
  • MJ4PTD2VVW
• RxNorm Concept Unique ID - RxCUI:
  • 579148
  • 310437
  • 310436

Pharmacological Class

• Cholinesterase Inhibitor [EPC]
• Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "Galantamine" or generic name "Galantamine"

NDC	Brand Name	Generic Name
0054-0090	Galantamine	Galantamine
0054-0091	Galantamine	Galantamine
0054-0092	Galantamine	Galantamine
0378-2721	Galantamine	galantamine
0378-2722	Galantamine	galantamine
0378-2723	Galantamine	galantamine
0591-3496	Galantamine	Galantamine
0591-3497	Galantamine	Galantamine
0591-3498	Galantamine	Galantamine
0615-7541	Galantamine	Galantamine
0615-7542	Galantamine	Galantamine
0615-7543	Galantamine	Galantamine
0904-7104	Galantamine	galantamine
51079-852	Galantamine	galantamine
51079-853	Galantamine	galantamine
57237-049	Galantamine	Galantamine
57237-050	Galantamine	Galantamine
68084-729	Galantamine	Galantamine
68382-177	galantamine	galantamine
68382-178	galantamine	galantamine
68382-179	galantamine	galantamine
70436-005	Galantamine	Galantamine
70436-004	Galantamine	Galantamine
70436-006	Galantamine	Galantamine
57237-051	Galantamine	Galantamine
60505-2542	Galantamine	Galantamine
60505-2543	Galantamine	Galantamine
60505-2544	Galantamine	Galantamine
63739-708	Galantamine	Galantamine
63739-999	Galantamine	Galantamine
65862-458	Galantamine	Galantamine
65862-745	Galantamine	Galantamine
65841-755	Galantamine	Galantamine
65862-459	Galantamine	Galantamine
65862-460	Galantamine	Galantamine
65862-746	Galantamine	Galantamine
65841-756	Galantamine	Galantamine
65841-757	Galantamine	Galantamine
65862-744	Galantamine	Galantamine