Hydrocodone Bitartrate and Acetaminophen NDC 63187-112

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0112Add 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
63187-112-15	63187011215	15 TABLET in 1 BOTTLE (63187-112-15)Marketed from Jun 2, 2014
63187-112-20	63187011220	20 TABLET in 1 BOTTLE (63187-112-20)Marketed from Jun 2, 2014
63187-112-30	63187011230	30 TABLET in 1 BOTTLE (63187-112-30)Marketed from Jun 2, 2014
63187-112-60	63187011260	60 TABLET in 1 BOTTLE (63187-112-60)Marketed from Jun 2, 2014

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 — 5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040736
Marketing start: Jan 18, 2010
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 63187-112_160e7aae-4a67-4845-9fa1-9d13afb5285dSPL ID 160e7aae-4a67-4845-9fa1-9d13afb5285dSPL set ID 50be5d00-758e-4d01-8e78-40a60dbe67e5RxCUI 857002UNII 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

N463187011215 followed by a unit qualifier and the quantity

Package 63187-0112-15. 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 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040736

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

FDA NDC Directory listings under ANDA 040736
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-5422
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-109
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-401
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-402