amantadine
- Product NDC
- 46708-246
- 11-digit product format
- 467080246
- Labeler code
- 46708
- Product ID
- 46708-246_db464488-fe29-445d-b8c1-b93554371798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA208966
- Marketing category
- ANDA
- Marketing start
- 2017-06-22
- 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
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-246-30 | 2023-02-01 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-31 | 2023-02-01 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-71 | 2023-02-01 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-91 | 2023-02-01 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-31 | 2023-01-30 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-71 | 2023-01-30 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
| 46708-246-91 | 2023-01-30 | C162847 | 48780-1 | f386c649-c8c9-0266-e053-dadaa90a7c1a | Amantadine Hydrochloride Capsules, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-246-30 | amantadine | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 46708-246-31 | amantadine | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 46708-246-71 | amantadine | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 46708-246-91 | amantadine | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-246 | AMANTADINE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230202_d8887814-3e56-447e-8bc3-add1861e0cf7.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 |
|---|
| 46708-246-30 | 46708024630 | 30 CAPSULE in 1 BOTTLE (46708-246-30) | 30 capsule | 2017-06-22 | 0000-00-00 | No | No | Current |
| 46708-246-31 | 46708024631 | 100 CAPSULE in 1 BOTTLE (46708-246-31) | 100 capsule | 2017-06-22 | 0000-00-00 | No | No | Current |
| 46708-246-71 | 46708024671 | 500 CAPSULE in 1 BOTTLE (46708-246-71) | 500 capsule | 2017-06-22 | 0000-00-00 | No | No | Current |
| 46708-246-91 | 46708024691 | 1000 CAPSULE in 1 BOTTLE (46708-246-91) | 1000 capsule | 2017-06-22 | 0000-00-00 | No | No | Current |