Amantadine Hydrochloride
- Product NDC
- 0527-1704
- 11-digit product format
- 005271704
- Labeler code
- 0527
- Product ID
- 0527-1704_d2c8dafb-7e51-4cea-a990-77a4ec35509c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA078720
- Marketing category
- ANDA
- Marketing start
- 2008-11-01
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 519d6abc-639d-2962-cced-abbf8b16aad4 | Product name | 7 | 20250401 |
| 82f46845-b4c7-48da-a389-ba5721b956c9 | Product name | 2 | 20250325 |
| d2c037c0-5ebf-d224-252f-2549922c21c7 | Product name | 7 | 20240208 |
| b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721 | Product name | 2 | 20220224 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| 14e11aaf-885f-472f-a02a-c6a3f28df907 | Product name | 1 | 20180515 |
| 82f46845-b4c7-48da-a389-ba5721b956c9 | Product name | 1 | 20171103 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1704-01 | EA - Each | 0527-1704 | 46692920-3f5a-4ae4-992b-0db9cf70e8ea | 1 | 2012-07-24 |
| 0527-1704-05 | EA - Each | 0527-1704 | f1e39425-d28f-4055-8277-e643a8016ec3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849389 | amantadine HCl 100 MG Oral Capsule | PSN | a2caed21-e9a3-228e-70a8-de30a1b368be | 3 |
| 849389 | amantadine hydrochloride 100 MG Oral Capsule | SCD | a2caed21-e9a3-228e-70a8-de30a1b368be | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-1704-01 | 00527170401 | 100 CAPSULE in 1 BOTTLE (0527-1704-01) | 100 capsule | 2008-11-01 | 0000-00-00 | No | No | Current |
| 0527-1704-05 | 00527170405 | 500 CAPSULE in 1 BOTTLE (0527-1704-05) | 500 capsule | 2008-11-01 | 0000-00-00 | No | No | Current |