Acetaminophen and Codeine Phosphate NDC 64380-446

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0446Add 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
64380-446-01	64380044601	100 TABLET in 1 BOTTLE (64380-446-01)Marketed from May 20, 2024
64380-446-02	64380044602	1000 TABLET in 1 BOTTLE (64380-446-02)Marketed from May 20, 2024
64380-446-03	64380044603	500 TABLET in 1 BOTTLE (64380-446-03)Marketed from May 20, 2024

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 Phosphate
Generic name (nonproprietary): acetaminophen and codeine phosphate
Active ingredients: Acetaminophen — 300 mg/1Codeine phosphate — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089805
Marketing start: May 20, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64380-446_c87671eb-3ec7-4930-be25-5686a75679deSPL ID c87671eb-3ec7-4930-be25-5686a75679deSPL set ID c459ed02-afd6-4533-82b6-bfb2c7ab0e72RxCUI 993770, 993781, 993890UNII GSL05Y1MN6, 362O9ITL9DUPC 0364380448013, 0364380446019, 0364380447016
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

N464380044601 followed by a unit qualifier and the quantity

Package 64380-0446-01. 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 May 20, 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 been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Acetaminophen and codeine phosphate tab…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 089805

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

FDA NDC Directory listings under ANDA 089805
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-2916
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	82804-181
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0527
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-938
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-4104
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3824