Galantamine
- Product NDC
- 70436-005
- 11-digit product format
- 704360005
- Labeler code
- 70436
- Product ID
- 70436-005_4685d03a-2fae-235e-e063-6394a90afd77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- galantamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA077604
- Marketing category
- ANDA
- Marketing start
- 2017-08-02
- Substance
- GALANTAMINE HYDROBROMIDE
- Active strength
- 8 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GALANTAMINE HYDROBROMIDE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MJ4PTD2VVW |
| Rxcui | 310436, 310437, 579148 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-005-06 | Galantamine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-005 | GALANTAMINE TABLET, FILM COATED [SLATE RUN PHARMACEUTICALS, LLC] | 12 | Current NDC, Legacy NDC, 1 package rows | 20241208_56f365e5-0a23-4f69-e054-00144ff8d46c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70436-005-06 | 70436000506 | 60 TABLET, FILM COATED in 1 BOTTLE (70436-005-06) | 2017-08-02 | 0000-00-00 | No | No | Current |