OSMOLEX ER
- Product NDC
- 70482-076
- 11-digit product format
- 704820076
- Labeler code
- 70482
- Product ID
- 70482-076_8321bb20-293e-4848-b1be-3116bf9ca476
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Adamas Pharma, LLC
- Application
- NDA209410
- Marketing category
- NDA
- Marketing start
- 2018-06-01
- Marketing end
- 0000-00-00
- Substance
- AMANTADINE HYDROCHLORIDE
- Active strength
- 193 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70482-076 | OSMOLEX ER (AMANTADINE) TABLET, EXTENDED RELEASE [ADAMAS PHARMA, LLC] | 10 | Legacy NDC | 20241012_6fbddb66-8b9d-4d37-a348-abcc31276e89.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70482-076-07 | 70482007607 | 2 BLISTER PACK in 1 CARTON (70482-076-07) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2018-06-01 | 0000-00-00 | Yes | No | Current |
| 70482-076-14 | 70482007614 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-14) | | 2018-06-01 | 0000-00-00 | Yes | No | Current |
| 70482-076-30 | 70482007630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70482-076-30) | | 2018-06-01 | 0000-00-00 | No | No | Current |