What is NDC 72189-406?

72189-406 is the product NDC for Hydrocodone/Apap, Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydrocodone/Apap?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydrocodone/Apap NDC 72189-406 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-406Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0406Add 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
72189-406-30	72189040630	30 TABLET in 1 BOTTLE (72189-406-30)Marketed from Dec 15, 2022
72189-406-60	72189040660	60 TABLET in 1 BOTTLE (72189-406-60)Marketed from Dec 15, 2022
72189-406-90	72189040690	90 TABLET in 1 BOTTLE (72189-406-90)Marketed from Dec 15, 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/Apap
Generic name (nonproprietary): hydrocodone/apap
Active ingredients: Hydrocodone bitartrate — 7.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040405
Marketing start: Dec 15, 2022
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-406_2c4cdc9e-f775-a44a-e063-6294a90a3c96SPL ID 2c4cdc9e-f775-a44a-e063-6294a90a3c96SPL set ID efe3b2eb-5c26-3783-e053-2995a90a6ba8RxCUI 857005UNII 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

N472189040630 followed by a unit qualifier and the quantity

Package 72189-0406-30. 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 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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, 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)

About NDC 72189-406

What is NDC 72189-406?: 72189-406 is the product NDC for Hydrocodone/Apap, Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydrocodone/Apap.
What is the active ingredient?: Hydrocodone bitartrate, Acetaminophen.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocodone/Apap?: 4 other product NDCs are listed under this name. See all Hydrocodone/Apap NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydrocodone/Apap NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocodone/APAP	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-649	72189-0649-2072189-0649-3072189-0649-60
Hydrocodone/APAP	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-650	72189-0650-3072189-0650-60
Hydrocodone/APAP	Acetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1	TabletOral	Direct_Rx	72189-407	72189-0407-3072189-0407-6072189-0407-72+1 more
Hydrocodone APAP	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-352	72189-0352-3072189-0352-6072189-0352-72+1 more

Other NDCs under ANDA 040405

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

FDA NDC Directory listings under ANDA 040405
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	SpecGx LLC	0406-0124