Memantine hydrochloride
- Product NDC
- 68382-549
- 11-digit product format
- 683820549
- Labeler code
- 68382
- Product ID
- 68382-549_079cb172-4d62-4571-98b9-5ad01706dbee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203293
- Marketing category
- ANDA
- Marketing start
- 2018-04-08
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 28 mg/1
- Pharmacologic classes
- N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Memantine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 28 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996594, 996603, 996609, 996615 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-549-06 | Memantine hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
| 68382-549-16 | Memantine hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 5 |
| 68382-549-30 | Memantine hydrochloride | 10 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 10 | | 5 |
| 68382-549-77 | Memantine hydrochloride | 10 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-549 | MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231110_eac265e6-6ea4-4368-acff-2efe6a8dd40a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-549-06 | 68382054906 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-549-06) | | 2018-04-08 | 0000-00-00 | No | No | Current |
| 68382-549-16 | 68382054916 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-549-16) | | 2018-04-08 | 0000-00-00 | No | No | Current |
| 68382-549-30 | 68382054930 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-549-77 | 68382054977 | 10 BLISTER PACK in 1 CARTON (68382-549-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-549-30) | 10 blister pack | 2018-04-08 | 0000-00-00 | No | No | Current |