Memantine Hydrochloride
- Product NDC
- 0378-5436
- 11-digit product format
- 003785436
- Labeler code
- 0378
- Product ID
- 0378-5436_642189b4-b4ad-424a-9c89-4dcbde5b2773
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206032
- Marketing category
- ANDA
- Marketing start
- 2018-02-26
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 14 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5436-77 | 00378543677 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5436-77) | 2018-02-26 | 0000-00-00 | No | No | Current |
| 0378-5436-93 | 00378543693 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5436-93) | 2018-02-26 | 0000-00-00 | No | No | Current |