Acetaminophen and Codeine Phosphate NDC 64380-447

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-447Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0447Add 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	Copy
64380-447-01	64380044701	100 TABLET in 1 BOTTLE (64380-447-01)Marketed from May 20, 2024
64380-447-02	64380044702	500 TABLET in 1 BOTTLE (64380-447-02)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 — 60 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 089828
Marketing start: May 20, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64380-447_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

N464380044701 followed by a unit qualifier and the quantity

Package 64380-0447-01. 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

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