Acetaminophen And Codeine Phosphate NDC 63629-3031

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-3031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-3031Add 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
63629-3031-0	63629303100	100 TABLET in 1 BOTTLE (63629-3031-0)Marketed from Mar 25, 2021
63629-3031-1	63629303101	30 TABLET in 1 BOTTLE (63629-3031-1)Marketed from Jul 18, 2006
63629-3031-2	63629303102	120 TABLET in 1 BOTTLE (63629-3031-2)Marketed from Feb 2, 2006
63629-3031-3	63629303103	60 TABLET in 1 BOTTLE (63629-3031-3)Marketed from Jul 18, 2006
63629-3031-4	63629303104	90 TABLET in 1 BOTTLE (63629-3031-4)Marketed from Jan 3, 2007
63629-3031-5	63629303105	40 TABLET in 1 BOTTLE (63629-3031-5)Marketed from Apr 29, 2009
63629-3031-6	63629303106	20 TABLET in 1 BOTTLE (63629-3031-6)Marketed from Mar 1, 2011
63629-3031-7	63629303107	112 TABLET in 1 BOTTLE (63629-3031-7)Marketed from Feb 15, 2012
63629-3031-8	63629303108	84 TABLET in 1 BOTTLE (63629-3031-8)Marketed from Feb 15, 2012
63629-3031-9	63629303109	15 TABLET in 1 BOTTLE (63629-3031-9)Marketed from Feb 9, 2022

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): Acetaminophen And Codeine Phosphate
Generic name (nonproprietary): acetaminophen and codeine phosphate
Active ingredients: Acetaminophen — 300 mg/1Codeine phosphate — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
Marketing start: May 31, 2001
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63629-3031_761159a0-fffc-43ca-b8bf-66f205460960SPL ID 761159a0-fffc-43ca-b8bf-66f205460960SPL set ID 18315a6f-9e89-46d7-81d3-905b8a51aa79RxCUI 993890UNII 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

N463629303100 followed by a unit qualifier and the quantity

Package 63629-3031-00. 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 Aug 22, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 ), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated. Acetaminophen and codeine phosphate t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040419

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

FDA NDC Directory listings under ANDA 040419
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-009
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4475
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4533
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	SpecGx LLC	0406-0483
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	SpecGx LLC	0406-0484
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	SpecGx LLC	0406-0485
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Quality Care Products, LLC	49999-060
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1522
Acetaminophen And Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Direct_Rx	61919-484
Acetaminophen And Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Direct_Rx	61919-484
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-0485
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	63629-5666
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	A-S Medication Solutions	50090-4610
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	A-S Medication Solutions	50090-4611
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-4484
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	67544-003
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7835
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	67544-002
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	63187-106
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7859

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