NDC 0591-3497

Galantamine

Galantamine

Galantamine is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Galantamine Hydrobromide.

• Product ID: 0591-3497_318d373a-e909-4d30-b9bd-60e136fe7569
• NDC: 0591-3497
• Product Type: Human Prescription Drug
• Proprietary Name: Galantamine
• Generic Name: Galantamine
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-12-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079028
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: GALANTAMINE HYDROBROMIDE
• Active Ingredient Strength: 16 mg/1
• Pharm Classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0591-3497-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3497-30)

• Marketing Start Date: 2008-12-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3497-05 [00591349705]

Galantamine CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079028
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-12-15
• Marketing End Date: 2008-12-15

NDC 0591-3497-30 [00591349730]

Galantamine CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA079028
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-12-16

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	16 mg/1

OpenFDA Data

• SPL SET ID: a074f2c6-fc31-4b04-80da-b905abe839b5
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • MJ4PTD2VVW
• RxNorm Concept Unique ID - RxCUI:
  • 860695
  • 860707
  • 860715

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