Amantadine HCl
- Product NDC
- 50268-069
- 11-digit product format
- 502680069
- Labeler code
- 50268
- Product ID
- 50268-069_38566e1f-b7b1-540f-e063-6394a90a2760
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA078720
- Marketing category
- ANDA
- Marketing start
- 2014-03-28
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC], M2 Protein 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
- Amantadine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMANTADINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M6Q1EO9TD0 |
| Rxcui | 849389 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-069-11 | Amantadine HCl | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 10 |
| 50268-069-15 | Amantadine HCl | 50 in 1 BOX, UNIT-DOSE | CAPSULE, LIQUID FILLED | 50 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMANTADINE HYDROCHLORIDE | ACTIVE INGREDIENT | M6Q1EO9TD0 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| AMANTADINE | ACTIVE MOIETY | BF4C9Z1J53 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-069 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AVPAK] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220118_461e6444-189e-62ed-6c61-1c36a04459c6.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 |
|---|
| 50268-069-11 | 50268006911 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-069-15 | 50268006915 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11) | 50 blister pack | 2014-03-28 | 0000-00-00 | No | No | Current |