Galantamine Hydrobromide
- Product NDC
- 0054-0137
- 11-digit product format
- 000540137
- Labeler code
- 0054
- Product ID
- 0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Galantamine Hydrobromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA078185
- Marketing category
- ANDA
- Marketing start
- 2009-08-14
- Substance
- GALANTAMINE HYDROBROMIDE
- Active strength
- 4 mg/mL
- 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 | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MJ4PTD2VVW |
| Rxcui | 860901 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0137-49 | Galantamine Hydrobromide | 100 mL in 1 BOTTLE | SOLUTION | 100 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0137 | GALANTAMINE HYDROBROMIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240110_d5b0e225-e94d-4324-afb2-b6e51c949dd0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0137-49 | 00054013749 | 100 mL in 1 BOTTLE (0054-0137-49) | 100 ml | 2009-08-14 | 0000-00-00 | No | No | Current |