Hydrocodone Bitartrate and Acetaminophen NDC 67296-2166

NDC codes

FDA NDC Directory

Product NDC (as listed)67296-2166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67296-2166Add 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
67296-2166-1	67296216601	118 mL in 1 BOTTLE (67296-2166-1)Marketed from Apr 8, 2019

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/15mLAcetaminophen — 325 mg/15mL
Dosage form: Solution
Route: Oral
Labeler: Redpharm Drug
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211023
Marketing start: Apr 8, 2019
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 67296-2166_45abe132-b49c-8490-e063-6294a90ad6bfSPL ID 45abe132-b49c-8490-e063-6294a90ad6bfSPL set ID 37451478-b961-873b-e063-6394a90a7b4eRxCUI 856940UNII NO70W886KK, 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

N467296216601 followed by a unit qualifier and the quantity

Package 67296-2166-01. 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 11, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen oral solution 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 oral solution 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 211023

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

FDA NDC Directory listings under ANDA 211023
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL	SolutionOral	American Health Packaging	60687-417
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL	SolutionOral	Eywa Pharma Inc	71930-027