What is NDC 63187-824?

63187-824 is the product NDC for Oxycodone and Acetaminophen, Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 7 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Oxycodone hydrochloride, Acetaminophen.

Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oxycodone and Acetaminophen?

110 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone and Acetaminophen NDC 63187-824

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-824Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0824Add 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
63187-824-10	6318708241063187082410	10 TABLET in 1 BOTTLE, PLASTIC (63187-824-10)Marketed from Dec 1, 2017
63187-824-12	6318708241263187082412	12 TABLET in 1 BOTTLE, PLASTIC (63187-824-12)Marketed from Mar 1, 2017
63187-824-15	6318708241563187082415	15 TABLET in 1 BOTTLE, PLASTIC (63187-824-15)Marketed from Aug 28, 2014
63187-824-20	6318708242063187082420	20 TABLET in 1 BOTTLE, PLASTIC (63187-824-20)Marketed from Aug 28, 2014
63187-824-30	6318708243063187082430	30 TABLET in 1 BOTTLE, PLASTIC (63187-824-30)Marketed from Mar 1, 2017
63187-824-60	6318708246063187082460	60 TABLET in 1 BOTTLE, PLASTIC (63187-824-60)Marketed from Mar 1, 2017
63187-824-90	6318708249063187082490	90 TABLET in 1 BOTTLE, PLASTIC (63187-824-90)Marketed from Mar 1, 2017

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 — 5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201278
Marketing start: Aug 28, 2014
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63187-824_9f711da8-c5d3-42ae-a8bc-bfdc75b1baf3SPL ID 9f711da8-c5d3-42ae-a8bc-bfdc75b1baf3SPL set ID ad03068c-1af4-46ce-bdea-c2745b1c1e52RxCUI 1049221UNII C1ENJ2TE6C, 362O9ITL9DUPC 0363187824303
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

N463187082410 followed by a unit qualifier and the quantity

Package 63187-0824-10. 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 Oct 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP 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, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-824

What is NDC 63187-824?: 63187-824 is the product NDC for Oxycodone and Acetaminophen, Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone and Acetaminophen.
What is the active ingredient?: Oxycodone hydrochloride, Acetaminophen.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxycodone and Acetaminophen?: 110 other product NDCs are listed under this name. See all Oxycodone and Acetaminophen NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oxycodone and Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-898	60760-0898-3060760-0898-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-899	60760-0899-3060760-0899-6060760-0899-90
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-897	60760-0897-3060760-0897-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-368	72189-0368-3072189-0368-6072189-0368-72+1 more
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-642	60687-0642-01
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-668	70010-0668-0170010-0668-05
Oxycodone and Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-667	70010-0667-0170010-0667-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-669	70010-0669-0170010-0669-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-670	70010-0670-0170010-0670-05
Oxycodone And Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1	TabletOral	DIRECT RX	72189-256	72189-0256-3072189-0256-6072189-0256-72

All 111 Oxycodone and Acetaminophen NDCs

Other NDCs under ANDA 201278

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

FDA NDC Directory listings under ANDA 201278
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1492
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-898
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1909
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-9501
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	RedPharm Drug	67296-1937
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-136
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-209
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8876
Oxycodone/APAP	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-375
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1338
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1339
Percocetoxycodone/apap	Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1	TabletOral	Direct_Rx	72189-397
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1420
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-102
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-103
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Rhodes Pharmaceuticals LLC	42858-104
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1472