Amantadine Hydrochloride
- Product NDC
- 0832-0111
- 11-digit product format
- 008320111
- Labeler code
- 0832
- Product ID
- 0832-0111_45af44df-1a9b-32b6-e063-6394a90acdaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA076186
- Marketing category
- ANDA
- Marketing start
- 2011-12-15
- Marketing end
- 2028-02-29
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amantadine Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMANTADINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M6Q1EO9TD0 |
| Rxcui | 849395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-0111-00 | Amantadine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 0832-0111-03 | Amantadine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 11 |
| 0832-0111-50 | Amantadine Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
| 0832-0111-89 | Amantadine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| amantadine hydrochloride | ACTIVE INGREDIENT | M6Q1EO9TD0 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| amantadine | ACTIVE MOIETY | BF4C9Z1J53 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-0111 | AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20230519_63d9d4aa-5f92-45b0-98d0-d6ec38b727cb.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 |
|---|
| 0832-0111-00 | 00832011100 | 100 TABLET in 1 BOTTLE (0832-0111-00) | 100 tablet | 2011-12-15 | 2028-02-29 | No | No | Current |
| 0832-0111-03 | 00832011103 | 100 BLISTER PACK in 1 CARTON (0832-0111-03) / 1 TABLET in 1 BLISTER PACK (0832-0111-89) | 100 blister pack | 2017-07-07 | 2026-08-31 | No | No | Current |
| 0832-0111-50 | 00832011150 | 500 TABLET in 1 BOTTLE (0832-0111-50) | 500 tablet | 2011-12-15 | 2028-02-29 | No | No | Current |
| 0832-0111-89 | 00832011189 | 1 in 1 BLISTER PACK | | | | | | Historical |