Hydrocodone Bitartrate and Acetaminophen NDC 68071-2494

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-2494Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-2494Add 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
68071-2494-2	68071249402	12 TABLET in 1 BOTTLE (68071-2494-2)Marketed from Aug 5, 2021
68071-2494-6	68071249406	6 TABLET in 1 BOTTLE (68071-2494-6)Marketed from Aug 5, 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): Hydrocodone Bitartrate and Acetaminophen
Generic name (nonproprietary): hydrocodone bitartrate and acetaminophen
Active ingredients: Hydrocodone bitartrate — 7.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210211
Marketing start: Jul 13, 2018
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 68071-2494_14a72a34-8d02-37f6-e063-6394a90aed3bSPL ID 14a72a34-8d02-37f6-e063-6394a90aed3bSPL set ID c8d65aab-d6ae-bc69-e053-2a95a90a7b5eRxCUI 857005UNII NO70W886KK, 362O9ITL9DUPC 0368071249460
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

N468071249402 followed by a unit qualifier and the quantity

Package 68071-2494-02. 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 Mar 27, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablet is indicated for the management of pain severe enough to require an opioid analgesic 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 Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210211

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

FDA NDC Directory listings under ANDA 210211
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone/APAP	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-649
Hydrocodone/APAP	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-650
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2116
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8885
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-8886
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-2144
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Redpharm Drug	67296-2201
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1989
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1990
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	72162-1991
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-051
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-049
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	87063-050
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3447
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-1939
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-1938
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-1940
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1970
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-396
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-407

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