Acetaminophen And Codeine Phosphate NDC 50090-4610

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-4610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-4610Add 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
50090-4610-0	50090461000	10 TABLET in 1 BOTTLE (50090-4610-0)Marketed from Oct 15, 2019
50090-4610-1	50090461001	12 TABLET in 1 BOTTLE (50090-4610-1)Marketed from Oct 15, 2019
50090-4610-2	50090461002	15 TABLET in 1 BOTTLE (50090-4610-2)Marketed from Oct 15, 2019
50090-4610-3	50090461003	20 TABLET in 1 BOTTLE (50090-4610-3)Marketed from Oct 15, 2019
50090-4610-4	50090461004	30 TABLET in 1 BOTTLE (50090-4610-4)Marketed from Oct 15, 2019
50090-4610-7	50090461007	100 TABLET in 1 BOTTLE (50090-4610-7)Marketed from Oct 15, 2019

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 — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
Marketing start: May 31, 2001
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23SPL ID a18dafdc-8a81-4129-bbc4-808083c24b23SPL set ID dff53120-a609-4720-bd69-2391798c7deeRxCUI 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

N450090461000 followed by a unit qualifier and the quantity

Package 50090-4610-00. 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 Jan 22, 2026. 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, 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 acetaminophen and codeine phosphate 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 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 60 mg/1	TabletOral	Bryant Ranch Prepack	63629-3031
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	50090-4611
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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