Amantadine HCl
- Product NDC
- 63629-2681
- 11-digit product format
- 636292681
- Labeler code
- 63629
- Product ID
- 63629-2681_a2e36bef-667f-423e-9ef6-90989e087400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-2681-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3b59-f424-e053-dadaa90a57ce | AMANTADINE HCL |
| 63629-2681-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3b59-f424-e053-dadaa90a57ce | AMANTADINE HCL |
| 63629-2681-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3b59-f424-e053-dadaa90a57ce | AMANTADINE HCL |
| 63629-2681-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3b59-f424-e053-dadaa90a57ce | AMANTADINE HCL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-2681-1 | Amantadine HCl | 20 in 1 BOTTLE | CAPSULE | 20 | 3 | |
| 63629-2681-2 | Amantadine HCl | 30 in 1 BOTTLE | CAPSULE | 30 | 3 | |
| 63629-2681-3 | Amantadine HCl | 10 in 1 BOTTLE | CAPSULE | 10 | 3 | |
| 63629-2681-4 | Amantadine HCl | 14 in 1 BOTTLE | CAPSULE | 14 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2681-1 | EA - Each | 63629-2681 | 7843840d-f3b6-4e6f-885c-d0b84ffa3ddc | 1 | 2012-07-24 |
| 63629-2681-2 | EA - Each | 63629-2681 | 3bcda13f-77b6-413d-a6fb-2595b84166ff | 1 | 2012-07-24 |
| 63629-2681-3 | EA - Each | 63629-2681 | eecf2d8c-0c56-4e81-86a9-a272cc1849c4 | 1 | 2012-07-24 |
| 63629-2681-4 | EA - Each | 63629-2681 | 684344c9-55a1-474b-8669-35fa715a93eb | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2681 | AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK] | 3 | Legacy NDC, 4 package rows | 20121016_a2caed21-e9a3-228e-70a8-de30a1b368be.zip |
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 | Status |
|---|---|---|---|
| 63629-2681-1 | 63629268101 | 20 in 1 BOTTLE | Historical |
| 63629-2681-2 | 63629268102 | 30 in 1 BOTTLE | Historical |
| 63629-2681-3 | 63629268103 | 10 in 1 BOTTLE | Historical |
| 63629-2681-4 | 63629268104 | 14 in 1 BOTTLE | Historical |