Oxycodone Hydrochloride

Product NDC
31722-484
11-digit product format
317220484
Labeler code
31722
Product ID
31722-484_a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals Inc
Application
ANDA207418
Marketing category
ANDA
Marketing start
2025-11-14
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-484-0131722048401100 TABLET in 1 BOTTLE (31722-484-01) 100 tablet2025-11-14NoNoHistorical
31722-484-0531722048405500 TABLET in 1 BOTTLE (31722-484-05) 500 tablet2025-11-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxycodone HydrochlorideCamber Pharmaceuticals Inc | Ascent Pharmaceuticals Inc2026-01-14HUMAN PRESCRIPTION DRUG LABEL7