Galantamine Hydrobromide
- Product NDC
- 63629-2365
- 11-digit product format
- 636292365
- Labeler code
- 63629
- Product ID
- 63629-2365_1f5f7a01-fa97-4448-b3a2-755e8271cbeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Galantamine Hydrobromide
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090178
- Marketing category
- ANDA
- Marketing start
- 2011-02-09
- Substance
- GALANTAMINE HYDROBROMIDE
- Active strength
- 16 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Galantamine Hydrobromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GALANTAMINE HYDROBROMIDE | 16 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MJ4PTD2VVW |
| Rxcui | 860695 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-2365-1 | Galantamine Hydrobromide | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2365 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20240814_3059d10f-fb3d-4cbd-b936-104608889b67.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2365-1 | 63629236501 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2365-1) | 2011-02-09 | 0000-00-00 | No | No | Current |