What is NDC 72189-399?

72189-399 is the product NDC for Norco (hydrocodone/apap), Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 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 Norco?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Norco NDC 72189-399 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-399Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0399Add 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
72189-399-30	7218903993072189039930	30 TABLET in 1 BOTTLE (72189-399-30)Marketed from Nov 23, 2022
72189-399-60	7218903996072189039960	60 TABLET in 1 BOTTLE (72189-399-60)Marketed from Nov 23, 2022
72189-399-72	7218903997272189039972	120 TABLET in 1 BOTTLE (72189-399-72)Marketed from Nov 23, 2022
72189-399-90	7218903999072189039990	90 TABLET in 1 BOTTLE (72189-399-90)Marketed from Nov 23, 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): Norco
Generic name (nonproprietary): hydrocodone/apap
Active ingredients: Hydrocodone bitartrate — 10 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 040400
Marketing start: Nov 23, 2022
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-399_2c4ce870-c59f-df00-e063-6394a90a9011SPL ID 2c4ce870-c59f-df00-e063-6394a90a9011SPL set ID ee248dfd-7aa7-7dcc-e053-2995a90af19fUNII 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

N472189039930 followed by a unit qualifier and the quantity

Package 72189-0399-30. 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 72189-399

What is NDC 72189-399?: 72189-399 is the product NDC for Norco (hydrocodone/apap), Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct_Rx. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Norco (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 Norco?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	SpecGx LLC	0406-0125
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Quality Care Products, LLC	55700-991
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

Norco (Hydrocodone/apap) NDC 72189-399