Prescription drug · ANDA

Oxycodone Hydrochloride (oxycodone) NDC 71335-1080

Oxycodone hydrochloride 15 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1080Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71335-1080-17133510800160 TABLET in 1 BOTTLE (71335-1080-1)Marketed from Jan 29, 2019
71335-1080-27133510800290 TABLET in 1 BOTTLE (71335-1080-2)Marketed from Jan 29, 2019
71335-1080-37133510800330 TABLET in 1 BOTTLE (71335-1080-3)Marketed from Feb 15, 2019
71335-1080-471335108004120 TABLET in 1 BOTTLE (71335-1080-4)Marketed from May 7, 2019
71335-1080-571335108005100 TABLET in 1 BOTTLE (71335-1080-5)Marketed from May 30, 2024
71335-1080-67133510800656 TABLET in 1 BOTTLE (71335-1080-6)Marketed from May 30, 2024
71335-1080-77133510800784 TABLET in 1 BOTTLE (71335-1080-7)Marketed from May 30, 2024
71335-1080-87133510800845 TABLET in 1 BOTTLE (71335-1080-8)Marketed from May 30, 2024
71335-1080-97133510800918 TABLET in 1 BOTTLE (71335-1080-9)Marketed from May 30, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Oxycodone Hydrochloride
Generic name (nonproprietary)
oxycodone
Active ingredients
Oxycodone hydrochloride — 15 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203638
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 71335-1080_b195b697-0b1f-4ed8-9ebf-21bb6c0bd552SPL ID b195b697-0b1f-4ed8-9ebf-21bb6c0bd552SPL set ID d248ceba-9492-4348-aa07-31c9c73a3620RxCUI 1049611UNII C1ENJ2TE6C
Pharmacologic class
Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471335108001 followed by a unit qualifier and the quantity

Package 71335-1080-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve oxycodone HCl tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone HCl tablets should not be used for an extende…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203638

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203638
ProductStrengthForm · routeLabelerProduct NDC
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack71335-0981
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 5 mg/1TabletOralMajor Pharmaceuticals0904-6966
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 20 mg/1TabletOralBryant Ranch Prepack71335-1023
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 5 mg/1TabletOralRedpharm Drug67296-2233
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 5 mg/1TabletOralAmneal Pharmaceuticals LLC65162-047
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 15 mg/1TabletOralMajor Pharmaceuticals0904-7180
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 20 mg/1TabletOralAmneal Pharmaceuticals LLC65162-050
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack71335-0677
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 10 mg/1TabletOralAmneal Pharmaceuticals LLC65162-048
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 15 mg/1TabletOralAmneal Pharmaceuticals LLC65162-049
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 30 mg/1TabletOralAmneal Pharmaceuticals LLC65162-051
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 5 mg/1TabletOralBryant Ranch Prepack72162-1811
Oxycodone HydrochlorideoxycodoneOxycodone hydrochloride 30 mg/1TabletOralBryant Ranch Prepack72162-1812
Oxycodone HydrochlorideOxycodone hydrochloride 15 mg/1TabletOralPrecision Dose, Inc.68094-005

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