Hydrocodone Bitartrate and Acetaminophen NDC 27808-049

NDC codes

FDA NDC Directory

Product NDC (as listed)27808-049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width27808-0049Add 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
27808-049-01	27808004901	473 mL in 1 BOTTLE, PLASTIC (27808-049-01)Marketed from Dec 30, 2022

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): 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: Cranbury Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201295
Marketing start: Dec 30, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 27808-049_dc790b2b-c3f6-428c-83f0-0781ded05d6eSPL ID dc790b2b-c3f6-428c-83f0-0781ded05d6eSPL set ID 57e1fe79-eb60-4f4f-bb38-6df0270d408fRxCUI 856940UNII NO70W886KK, 362O9ITL9DUPC 0327808049018
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

N427808004901 followed by a unit qualifier and the quantity

Package 27808-0049-01. 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 8, 2026. 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, 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 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 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)

Other NDCs under ANDA 201295

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

FDA NDC Directory listings under ANDA 201295
Product	Strength	Form · route	Labeler	Product NDC
hydrocodone bitartrate and acetaminophen	Hydrocodone bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL	SolutionOral	Cranbury Pharmaceuticals, LLC	27808-130