Amantadine Hydrochloride
- Product NDC
- 53002-3750
- 11-digit product format
- 530023750
- Labeler code
- 53002
- Product ID
- 53002-3750_71f267f9-81be-4458-a791-221b7162a115
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA209047
- Marketing category
- ANDA
- Marketing start
- 2017-07-31
- 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
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-3750-1 | Amantadine Hydrochloride | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3750 | AMANTADINE HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_cdb39380-192f-480d-99a4-316f638d5cf2.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 |
|---|
| 53002-3750-1 | 53002375001 | 10 CAPSULE in 1 BOTTLE (53002-3750-1) | 10 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |