Hydromorphone Hydrochloride
- Product NDC
- 0406-3312
- 11-digit product format
- 004063312
- Labeler code
- 0406
- Product ID
- 0406-3312_28972b16-c7ed-400e-b52b-fff5d764ec39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA021217
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-05-16
- Marketing end
- 2021-03-31
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 12 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0406-3312-01 | 00406331201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3312-01) | 2014-05-16 | 2021-03-31 | No | No | Current |