AMANTADINE HYDROCHLORIDE
- Product NDC
- 61037-484
- 11-digit product format
- 610370484
- Labeler code
- 61037
- Product ID
- 61037-484_38fc829b-496d-024d-e063-6294a90a11b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMANTADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- BAJAJ MEDICAL, LLC
- Application
- ANDA075819
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 50 mg/5mL
- 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
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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721 | Product name | 2 | 20220224 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 14e11aaf-885f-472f-a02a-c6a3f28df907 | Product name | 1 | 20180515 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 82f46845-b4c7-48da-a389-ba5721b956c9 | Product name | 1 | 20171103 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61037-484-03 | AMANTADINE HYDROCHLORIDE | 473 mL in 1 BOTTLE | SOLUTION | 473 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849385 | amantadine HCl 50 MG in 5 mL Oral Solution | PSN | 38fccce5-1f1e-9350-e063-6394a90a045a | 1 |
| 849385 | amantadine hydrochloride 10 MG/ML Oral Solution | SCD | 38fccce5-1f1e-9350-e063-6394a90a045a | 1 |
| 849385 | amantadine hydrochloride 100 MG per 10 ML Oral Solution | SY | 38fccce5-1f1e-9350-e063-6394a90a045a | 1 |
| 849385 | amantadine hydrochloride 50 MG per 5 ML Oral Solution | SY | 38fccce5-1f1e-9350-e063-6394a90a045a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61037-484-03 | 61037048403 | 473 mL in 1 BOTTLE (61037-484-03) | 473 ml | 2025-07-31 | No | No | Historical |