NDC 0054-0091

Galantamine

Galantamine

Galantamine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Galantamine Hydrobromide.

• Product ID: 0054-0091_37835c90-3b88-4b93-8645-4f9693cb0457
• NDC: 0054-0091
• Product Type: Human Prescription Drug
• Proprietary Name: Galantamine
• Generic Name: Galantamine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077608
• Labeler Name: West-Ward Pharmaceuticals Corp.
• Substance Name: GALANTAMINE HYDROBROMIDE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0054-0091-21

60 TABLET in 1 BOTTLE (0054-0091-21)

• Marketing Start Date: 2016-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0091-20 [00054009120]

Galantamine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077608
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-01
• Marketing End Date: 2016-08-30

NDC 0054-0091-29 [00054009129]

Galantamine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077608
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-06-01
• Marketing End Date: 2016-08-30

NDC 0054-0091-21 [00054009121]

Galantamine TABLET

• Marketing Category: ANDA
• Application Number: ANDA077608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-05
• Marketing End Date: 2020-08-23

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	8 mg/1

OpenFDA Data

• SPL SET ID: d5b0e225-e94d-4324-afb2-b6e51c949dd0
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • MJ4PTD2VVW
• RxNorm Concept Unique ID - RxCUI:
  • 579148
  • 860901
  • 310437
  • 310436
• UPC Code:
  • 0300540137496

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