What is NDC 68071-3658?

68071-3658 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 68071-3658

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3658Add 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
68071-3658-2	6807136580268071365802	20 TABLET in 1 BOTTLE (68071-3658-2)Marketed from Jan 14, 2025
68071-3658-3	6807136580368071365803	30 TABLET in 1 BOTTLE (68071-3658-3)Marketed from Jul 31, 2024
68071-3658-5	6807136580568071365805	15 TABLET in 1 BOTTLE (68071-3658-5)Marketed from Jul 31, 2024

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: NuCare Pharmaceuticals, Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211610
Marketing start: Aug 2, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68071-3658_2baebda6-c349-721c-e063-6394a90a3552SPL ID 2baebda6-c349-721c-e063-6394a90a3552SPL set ID 1e932a34-a7d3-e4ec-e063-6294a90a25b1RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6UPC 0368071365856
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

N468071365802 followed by a unit qualifier and the quantity

Package 68071-3658-02. 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 14, 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, 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 68071-3658

What is NDC 68071-3658?: 68071-3658 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, 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?: NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 211610

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

FDA NDC Directory listings under ANDA 211610
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-2628
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Redpharm Drug	67296-2239
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	REMEDYREPACK INC.	70518-2764
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	72162-2001
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	72162-2002
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-821
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	Eywa Pharma Inc	71930-054
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Eywa Pharma Inc	71930-055
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Eywa Pharma Inc	71930-056
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3651
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	63629-1190
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1818
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8882
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	71335-1846