What is NDC 76420-103?

76420-103 is the product NDC for Acetaminophen and Codeine, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

Asclemed USA, Inc., NDC labeler code 76420. 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 76420-103

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0103Add 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
76420-103-03	7642001030376420010303	3 TABLET in 1 BOTTLE (76420-103-03)Marketed from Oct 30, 2020
76420-103-10	7642001031076420010310	10 TABLET in 1 BOTTLE (76420-103-10)Marketed from Oct 30, 2020
76420-103-20	7642001032076420010320	20 TABLET in 1 BOTTLE (76420-103-20)Marketed from Oct 30, 2020
76420-103-30	7642001033076420010330	30 TABLET in 1 BOTTLE (76420-103-30)Marketed from Oct 30, 2020

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: Asclemed USA, Inc.NDC labeler code 76420
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 76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0SPL ID b2dde53b-af58-ce44-e053-2a95a90a8fe0SPL set ID 3f83ba75-9415-4ace-9416-04d666c005a2RxCUI 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

N476420010303 followed by a unit qualifier and the quantity

Package 76420-0103-03. 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 Oct 30, 2020. 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, even at recommended doses (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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-103

What is NDC 76420-103?: 76420-103 is the product NDC for Acetaminophen and Codeine, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. 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?: Asclemed USA, Inc., NDC labeler code 76420. 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	Proficient Rx LP	63187-491	63187-0491-2063187-0491-3063187-0491-60+1 more
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

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	Proficient Rx LP	63187-491
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