Oxycodone Hydrochloride
- Product NDC
- 50383-961
- 11-digit product format
- 503830961
- Labeler code
- 50383
- Product ID
- 50383-961_a32f4de0-1ae9-4caf-b9cb-e63340c43f92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA208817
- Marketing category
- ANDA
- Marketing start
- 2017-08-10
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- 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 |
|---|
| 50383-961 | OXYCODONE HYDROCHLORIDE SOLUTION [AKORN] | 10 | Legacy NDC | 20221112_bb0767d1-b0f8-4975-bf51-631c9fa1b9bb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-961-06 | 50383096106 | 4 TRAY in 1 CASE (50383-961-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-961-05) | 4 tray | 2017-08-10 | 0000-00-00 | No | No | Current |
| 50383-961-34 | 50383096134 | 1 BOTTLE in 1 CARTON (50383-961-34) > 500 mL in 1 BOTTLE | 1 bottle | 2017-08-10 | 0000-00-00 | No | No | Current |