Amantadine Hydrochloride
- Product NDC
- 68999-011
- 11-digit product format
- 689990011
- Labeler code
- 68999
- Product ID
- 68999-011_4651addb-4284-88e1-e063-6294a90a3d13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amantadine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC.
- Application
- ANDA074028
- Marketing category
- ANDA
- Marketing start
- 1993-06-28
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 100 mg/10mL
- 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 |
|---|---|---|---|---|---|---|
| 68999-011-24 | Amantadine Hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | 1 | |
| 68999-011-24 | Amantadine Hydrochloride | 2 in 1 BOX | SOLUTION | 2 | 1 | |
| 68999-011-59 | Amantadine Hydrochloride | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68999-011-24 | ML - Milliliter | 68999-011 | 0f2f9892-7537-49b3-a4ca-f8444295c2ef | 1 | 2026-03-17 |
| 68999-011-59 | ML - Milliliter | 68999-011 | 98e0b2a2-7a37-4b2a-8856-588377140961 | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849385 | amantadine HCl 50 MG in 5 mL Oral Solution | PSN | 3c448cb3-7996-4a83-a9ad-23a00a431fbe | 1 |
| 849385 | amantadine hydrochloride 10 MG/ML Oral Solution | SCD | 3c448cb3-7996-4a83-a9ad-23a00a431fbe | 1 |
| 849385 | amantadine hydrochloride 100 MG per 10 ML Oral Solution | SY | 3c448cb3-7996-4a83-a9ad-23a00a431fbe | 1 |
| 849385 | amantadine hydrochloride 50 MG per 5 ML Oral Solution | SY | 3c448cb3-7996-4a83-a9ad-23a00a431fbe | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68999-011-24 | 68999001124 | 2 TRAY in 1 BOX (68999-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68999-011-59) | 2 tray | 2025-12-17 | No | No | Historical |
| 68999-011-59 | 68999001159 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | Historical |