Hydrocodone Bitartrate And Acetaminophen NDC 0406-0125

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-0125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-0125Add 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
0406-0125-01	00406012501	100 TABLET in 1 BOTTLE (0406-0125-01)Marketed from Jul 26, 2000
0406-0125-05	00406012505	500 TABLET in 1 BOTTLE (0406-0125-05)Marketed from Jul 26, 2000
0406-0125-10	00406012510	1000 TABLET in 1 BOTTLE (0406-0125-10)Marketed from Jul 26, 2000
0406-0125-23	00406012523	1 TABLET in 1 BLISTER PACK (0406-0125-23)Marketed from Jul 26, 2000
0406-0125-62	00406012562	100 TABLET in 1 BLISTER PACK (0406-0125-62)Marketed from Jul 26, 2000

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040400
Marketing start: Jul 26, 2000
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-0125_748bcfb4-7b4c-420c-a9c8-c93fd481f3d9SPL ID 748bcfb4-7b4c-420c-a9c8-c93fd481f3d9SPL set ID 73c1059b-0c7d-42ef-9827-f018858fc447RxCUI 856999, 857002, 857005UNII NO70W886KK, 362O9ITL9DUPC 0304060124011, 0304060125018, 0304060123014
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

N400406012501 followed by a unit qualifier and the quantity

Package 00406-0125-01. 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 Apr 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are 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 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)

Other NDCs under ANDA 040400

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

FDA NDC Directory listings under ANDA 040400
Product	Strength	Form · route	Labeler	Product NDC
Norcohydrocodone/apap	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-399
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-871
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	82804-003
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Quality Care Products, LLC	55700-991