Galantamine Hydrobromide
- Product NDC
- 47335-836
- 11-digit product format
- 473350836
- Labeler code
- 47335
- Product ID
- 47335-836_3ddec6e9-e082-4c2d-a026-aee87736ef80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Galantamine Hydrobromide
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- 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, 860707, 860715 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-836-08 | Galantamine Hydrobromide | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 17 |
| 47335-836-18 | Galantamine Hydrobromide | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 17 |
| 47335-836-83 | Galantamine Hydrobromide | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 17 |
| 47335-836-88 | Galantamine Hydrobromide | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GALANTAMINE HYDROBROMIDE | ACTIVE INGREDIENT | MJ4PTD2VVW | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| GALANTAMINE | ACTIVE MOIETY | 0D3Q044KCA | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-836 | GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20231030_d1697161-ebe8-42b0-83e7-c9de4412546c.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 |
|---|
| 47335-836-08 | 47335083608 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-08) | 2011-02-09 | 0000-00-00 | No | No | Current |
| 47335-836-18 | 47335083618 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-18) | 2011-02-09 | 0000-00-00 | No | No | Current |
| 47335-836-83 | 47335083683 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-83) | 2011-02-09 | 0000-00-00 | No | No | Current |
| 47335-836-88 | 47335083688 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-836-88) | 2011-02-09 | 0000-00-00 | No | No | Current |