What is NDC 63187-719?

63187-719 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 5 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 63187-719

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-719Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0719Add 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
63187-719-12	6318707191263187071912	12 TABLET in 1 BOTTLE (63187-719-12)Marketed from Nov 1, 2016
63187-719-15	6318707191563187071915	15 TABLET in 1 BOTTLE (63187-719-15)Marketed from Jun 1, 2016
63187-719-20	6318707192063187071920	20 TABLET in 1 BOTTLE (63187-719-20)Marketed from Jun 1, 2016
63187-719-30	6318707193063187071930	30 TABLET in 1 BOTTLE (63187-719-30)Marketed from Jun 1, 2016
63187-719-60	6318707196063187071960	60 TABLET in 1 BOTTLE (63187-719-60)Marketed from Jun 1, 2016

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 202677
Marketing start: Mar 9, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63187-719_b9d14bcb-219d-406c-85c5-405c9e8b8508SPL ID b9d14bcb-219d-406c-85c5-405c9e8b8508SPL set ID 0233de1c-466b-4842-8604-6d879aa36a4bRxCUI 1049214, 1049221UNII 362O9ITL9D, 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

N463187071912 followed by a unit qualifier and the quantity

Package 63187-0719-12. 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 Nov 1, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-719

What is NDC 63187-719?: 63187-719 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 5 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 202677

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

FDA NDC Directory listings under ANDA 202677
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-196
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-229
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-230
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-897
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-899
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-363
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3683
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	68084-699
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	68084-710
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0146
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0216
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0316