Oxycodone and Acetaminophen NDC 13107-043

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-043Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0043Add 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 NDC	11-digit (billing)	Package
13107-043-01	13107004301	100 TABLET in 1 BOTTLE (13107-043-01)Marketed from Jul 15, 2013
13107-043-05	13107004305	500 TABLET in 1 BOTTLE (13107-043-05)Marketed from Jul 15, 2013
13107-043-30	13107004330	30 TABLET in 1 BOTTLE (13107-043-30)Marketed from Jul 15, 2013
13107-043-99	13107004399	1000 TABLET in 1 BOTTLE (13107-043-99)Marketed from Jul 15, 2013

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 and Acetaminophen
Generic name (nonproprietary): oxycodone and acetaminophen
Active ingredients: Oxycodone hydrochloride — 2.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurolife Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201972
Marketing start: Jul 15, 2013
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 13107-043_c86ebd1a-f32c-4a67-9a1b-ff0a3861c124SPL ID c86ebd1a-f32c-4a67-9a1b-ff0a3861c124SPL set ID 69df20d9-b1d5-47dc-9ff0-29987284f8c7RxCUI 1049214, 1049221, 1049225, 1049635UNII 362O9ITL9D, C1ENJ2TE6CUPC 0313107046018
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

N413107004301 followed by a unit qualifier and the quantity

Package 13107-0043-01. 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 Dec 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and acetaminophen 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201972

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

FDA NDC Directory listings under ANDA 201972
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-984
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1036
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Aurolife Pharma, LLC	13107-045
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Aurolife Pharma, LLC	13107-044
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Aurolife Pharma, LLC	13107-046
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-823