Memantine Hydrochloride
- Product NDC
- 68382-388
- 11-digit product format
- 683820388
- Labeler code
- 68382
- Product ID
- 68382-388_5cf85a8a-effe-4207-8b72-e91e8c4f4650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA090961
- Marketing category
- ANDA
- Marketing start
- 2017-09-28
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68382-388 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 68382-388 | 68382-388-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68382-388 | 68382-388-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68382-388 | 68382-388-10 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68382-388 | 68382-388-14 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68382-388 | 68382-388-77 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090961-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | |
| A090961-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090961-001 | AB |
| A090961-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090961-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A090961-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | REMEDYREPACK INC. | cbfd9d95-f50b-45ff-9857-9f1712c45e56 | 2026-04-08 | Warnings, Adverse reactions | 090961 ANDA090961 |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | DirectRx | d0839a2d-35f1-1f14-e053-2995a90ad549 | 2026-03-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3662b11a-354a-b683-e063-6394a90a0086 | 2025-05-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Coupler LLC | 2d54be77-75b2-76b3-e063-6294a90a0cc0 | 2025-02-04 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Zydus Lifesciences Limited | 514421f3-f525-43e8-aecc-8b2bbffd00dc | 2024-08-16 | 090961 ANDA090961 | |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | A-S Medication Solutions | f05e381f-850d-42ea-9dd8-6d1f8dac4f62 | 2024-05-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 0ad2246a-ffa0-43a0-8094-58279d3e3a74 | 2024-02-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | be919d34-e9f4-49c8-8145-2dcafb7cb88c | 2024-02-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cfddd01-6e1d-4ee0-9310-3fb371724e3d | 2023-10-04 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | bf395152-2885-4633-bf3f-2da46e7b79f1 | 2023-03-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 8bd5b908-f46a-4ced-9408-45984d716149 | 2023-03-24 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 54a12ddf-306b-4eb7-a7c3-c7b58df3b372 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | fac8c59b-5bf5-478e-8223-a5ecaa400625 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | c8f96b24-de66-4a17-b798-42b42a25e84c | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Viona Pharmaceuticals Inc | dcbdb62a-a4e2-4058-b73c-46005f2a5d51 | 2022-10-08 | Warnings, Adverse reactions | 090961 ANDA090961 |