What is NDC 68788-7835?

68788-7835 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-7835

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-7835Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-7835Add 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
68788-7835-1	6878878350168788783501	15 TABLET in 1 BOTTLE (68788-7835-1)Marketed from Jan 18, 2021
68788-7835-2	6878878350268788783502	20 TABLET in 1 BOTTLE (68788-7835-2)Marketed from Jan 18, 2021
68788-7835-3	6878878350368788783503	30 TABLET in 1 BOTTLE (68788-7835-3)Marketed from Jan 18, 2021
68788-7835-6	6878878350668788783506	60 TABLET in 1 BOTTLE (68788-7835-6)Marketed from Jan 18, 2021

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: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
Marketing start: Jan 18, 2021
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68788-7835_d9c158fb-cdde-46d5-8778-15ec066c4841SPL ID d9c158fb-cdde-46d5-8778-15ec066c4841SPL set ID 2453d635-989d-4569-96b3-4efaf61cca71RxCUI 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

N468788783501 followed by a unit qualifier and the quantity

Package 68788-7835-01. 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 Jan 14, 2026. 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 68788-7835

What is NDC 68788-7835?: 68788-7835 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 040419

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

FDA NDC Directory listings under ANDA 040419
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-0485
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1522
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-4484
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	A-S Medication Solutions	50090-3011
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	63187-106
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7859
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	SpecGx LLC	0406-0483
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	67544-002
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	67544-003
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	SpecGx LLC	0406-0484
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-009
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-581
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	63629-3031
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	A-S Medication Solutions	50090-4610
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-3705
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	SpecGx LLC	0406-0485
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	A-S Medication Solutions	50090-4611
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4475
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4533
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Direct_Rx	72189-376

Showing 20 of 23.