What is NDC 64850-642?

64850-642 is the product NDC for Acetaminophen and Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

Elite Laboratories, Inc., NDC labeler code 64850. 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 Phosphate?

67 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 Phosphate NDC 64850-642

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-642Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0642Add 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
64850-642-01	64850064201	100 TABLET in 1 BOTTLE (64850-642-01)Marketed from May 3, 2024
64850-642-05	64850064205	500 TABLET in 1 BOTTLE (64850-642-05)Marketed from Feb 10, 2025
64850-642-12	64850064212	120 TABLET in 1 BOTTLE (64850-642-12)Marketed from Sep 10, 2019

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: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212418
Marketing start: Sep 10, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64850-642_d61159a3-cb34-4931-8185-e1eb41654a8aSPL ID d61159a3-cb34-4931-8185-e1eb41654a8aSPL set ID 6286e128-1288-4dc0-b14b-f04a0e2a22f9RxCUI 993770, 993781, 993890UNII GSL05Y1MN6, 362O9ITL9D
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

N464850064201 followed by a unit qualifier and the quantity

Package 64850-0642-01. 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 Dec 1, 2025. 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)

About NDC 64850-642

What is NDC 64850-642?: 64850-642 is the product NDC for Acetaminophen and Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen and Codeine Phosphate.
What is the active ingredient?: Acetaminophen, Codeine phosphate.
Who is the labeler?: Elite Laboratories, Inc., NDC labeler code 64850. 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 Phosphate?: 67 other product NDCs are listed under this name. See all Acetaminophen and Codeine Phosphate 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 Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-009	87441-0009-01
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8881	68788-8881-0168788-8881-0368788-8881-06
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8882	68788-8882-0168788-8882-0368788-8882-06
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0527	80425-0527-0180425-0527-0280425-0527-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0528	80425-0528-0180425-0528-0280425-0528-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0529	80425-0529-0180425-0529-0280425-0529-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0530	80425-0530-0180425-0530-0280425-0530-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-4104	70518-4104-00
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-938	60760-0938-30
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Strides Pharma Science Limited	64380-446	64380-0446-0164380-0446-0264380-0446-03

All 68 Acetaminophen and Codeine Phosphate NDCs

Other NDCs under ANDA 212418

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

FDA NDC Directory listings under ANDA 212418
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	Elite Laboratories, Inc.	64850-641
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Elite Laboratories, Inc.	64850-643
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3798
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0529
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0530
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	82804-283