Amantadine HCl
- Product NDC
- 69387-100
- 11-digit product format
- 693870100
- Labeler code
- 69387
- Product ID
- 69387-100_ac286359-2ef9-44c7-aa7d-6ed9120debfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Banner Life Sciences LLC.
- Application
- ANDA078720
- Marketing category
- ANDA
- Marketing start
- 2015-09-07
- Marketing end
- 0000-00-00
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69387-100-01 | Amantadine HCl | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 2 |
| 69387-100-05 | Amantadine HCl | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | | 2 |
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 [BANNER LIFE SCIENCES LLC.] | 2 | |
| AMANTADINE | ACTIVE MOIETY | BF4C9Z1J53 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69387-100 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BANNER LIFE SCIENCES LLC.] | 2 | Legacy NDC, 2 package rows | 20150911_d6e6e111-38da-43a2-b6c4-15e69b720495.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69387-100-01 | 69387010001 | 100 in 1 BOTTLE | Historical |
| 69387-100-05 | 69387010005 | 500 in 1 BOTTLE | Historical |