Oxycodone Hydrochloride

Product NDC
31722-486
11-digit product format
317220486
Labeler code
31722
Product ID
31722-486_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
20 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

openFDA Listing Details

Product ID
31722-486_a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2e
SPL ID
a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2e
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Oxycodone Hydrochloride
Generic name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Marketing start
2025-11-14
Marketing category
ANDA
Application number
ANDA207418
Pharmacologic classes
Full Opioid Agonists [MoA]; Opioid Agonist [EPC]
DEA schedule
CII
Listing expiration
2027-12-31

openFDA Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE20 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiC1ENJ2TE6C
Rxcui1049611, 1049618, 1049621, 1049683, 1049686
Spl Set Id01db4606-d49c-4b10-a78a-1cf41880a9fb
Manufacturer NameCamber Pharmaceuticals Inc

openFDA Package Details

Package NDCDescriptionMarketing startSample
31722-486-01100 TABLET in 1 BOTTLE (31722-486-01)2025-11-14No
31722-486-05500 TABLET in 1 BOTTLE (31722-486-05)2025-11-14No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-486-0131722048601100 TABLET in 1 BOTTLE (31722-486-01) 100 tablet2025-11-14NoNoHistorical
31722-486-0531722048605500 TABLET in 1 BOTTLE (31722-486-05) 500 tablet2025-11-14NoNoHistorical

Related DailyMed Labels

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