Memantine Hydrochloride
- Product NDC
- 72606-515
- 11-digit product format
- 726060515
- Labeler code
- 72606
- Product ID
- 72606-515_c46fb7ce-bb2c-48ef-84ac-9da1a7fec412
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CELLTRION USA, INC.
- Application
- ANDA090073
- Marketing category
- ANDA
- Marketing start
- 2020-06-05
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- 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 |
|---|---|---|---|
| 94db636e-a074-45fd-8e8d-331920a99436 | Product name | 4 | 20250103 |
| 941773f8-a40e-0684-da08-ff9a143e6368 | Product name | 7 | 20231219 |
| 5b597f00-4538-4686-aa4e-3c60ed3788c8 | Product name | 2 | 20210511 |
| 1836e79a-a4d1-4087-2f2e-f878e8a1fef2 | Product name | 9 | 20151209 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72606-515-02 | 2025-03-14 | C162847 | 48780-1 | 2cef2736-a4d3-d83d-e063-dadaa90ab31f | b2b5d6e0-6f8c-4b3a-9466-5df67c6c6846 |
| 72606-515-04 | 2025-03-14 | C162847 | 48780-1 | 2cef2736-a4d3-d83d-e063-dadaa90ab31f | b2b5d6e0-6f8c-4b3a-9466-5df67c6c6846 |
| 72606-515-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a4d3-d83d-e063-dadaa90ab31f | b2b5d6e0-6f8c-4b3a-9466-5df67c6c6846 |
| 72606-515-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a4d3-d83d-e063-dadaa90ab31f | b2b5d6e0-6f8c-4b3a-9466-5df67c6c6846 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72606-515-02 | EA - Each | 72606-515 | 265cd519-fc8e-4b42-9deb-327b4d21526a | 1 | 2020-09-14 |
| 72606-515-04 | EA - Each | 72606-515 | 3bfe83a8-5308-4f5b-b512-09f295b1d89e | 1 | 2020-09-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996561 | memantine HCl 10 MG Oral Tablet | PSN | 6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0 | 100 |
| 996561 | memantine hydrochloride 10 MG Oral Tablet | SCD | 6ba63a8d-4cbe-45b8-b6cf-675557a8f6e0 | 100 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72606-515-02 | 72606051502 | 60 TABLET, FILM COATED in 1 BOTTLE (72606-515-02) | 2020-06-05 | 0000-00-00 | No | No | Current |
| 72606-515-04 | 72606051504 | 500 TABLET, FILM COATED in 1 BOTTLE (72606-515-04) | 2020-06-05 | 0000-00-00 | No | No | Current |