What is NDC 63187-491?

63187-491 is the product NDC for Acetaminophen and Codeine, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

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 Acetaminophen and Codeine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetaminophen and Codeine NDC 63187-491

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-491Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0491Add 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
63187-491-20	6318704912063187049120	20 TABLET in 1 BOTTLE (63187-491-20)Marketed from Feb 2, 2015
63187-491-30	6318704913063187049130	30 TABLET in 1 BOTTLE (63187-491-30)Marketed from Feb 2, 2015
63187-491-60	6318704916063187049160	60 TABLET in 1 BOTTLE (63187-491-60)Marketed from Feb 2, 2015
63187-491-90	6318704919063187049190	90 TABLET in 1 BOTTLE (63187-491-90)Marketed from Feb 2, 2015

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): Acetaminophen and Codeine
Generic name (nonproprietary): acetaminophen and codeine
Active ingredients: Acetaminophen — 300 mg/1Codeine phosphate — 30 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 040779
Marketing start: May 29, 2008
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63187-491_a4e384a6-1887-4053-8263-54fc51823174SPL ID a4e384a6-1887-4053-8263-54fc51823174SPL set ID 2472bb8a-88b7-4eec-8806-34adef0c9ab9RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6
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

N463187049120 followed by a unit qualifier and the quantity

Package 63187-0491-20. 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 Jan 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-491

What is NDC 63187-491?: 63187-491 is the product NDC for Acetaminophen and Codeine, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen and Codeine.
What is the active ingredient?: Acetaminophen, Codeine phosphate.
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 Acetaminophen and Codeine?: 5 other product NDCs are listed under this name. See all Acetaminophen and Codeine 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 Acetaminophen and Codeine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1772	67296-1772-0167296-1772-0567296-1772-06
Acetaminophen And Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Direct_Rx	61919-484	61919-0484-90
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-033	65162-0033-1065162-0033-1165162-0033-50
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-0545	71335-0545-0071335-0545-0171335-0545-02+7 more
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-103	76420-0103-0376420-0103-1076420-0103-20+1 more

Other NDCs under ANDA 040779

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

FDA NDC Directory listings under ANDA 040779
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-033
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1772
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-0545
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-103