What is NDC 72189-671?

72189-671 is the product NDC for Tramadol/APAP, Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 tablet, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Tramadol hydrochloride.

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 Tramadol/APAP?

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.

Tramadol/APAP NDC 72189-671 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-671Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0671Add 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
72189-671-60	7218906716072189067160	60 TABLET in 1 BOTTLE (72189-671-60)Marketed from Mar 30, 2026

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): Tramadol/APAP
Generic name (nonproprietary): tramadol/apap
Active ingredients: Acetaminophen — 325 mg/1Tramadol hydrochloride — 37.5 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 090485
Marketing start: Mar 30, 2026
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-671_4f1b668e-fb85-43a0-e063-6294a90af3efSPL ID 4f1b668e-fb85-43a0-e063-6294a90af3efSPL set ID 4e40f55e-1d8e-ce2f-e063-6294a90a7becRxCUI 836395UNII 362O9ITL9D, 9N7R477WCK
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

N472189067160 followed by a unit qualifier and the quantity

Package 72189-0671-60. 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 10, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-671

What is NDC 72189-671?: 72189-671 is the product NDC for Tramadol/APAP, Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 tablet, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tramadol/APAP.
What is the active ingredient?: Acetaminophen, Tramadol hydrochloride.
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 Tramadol/APAP?: 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 090485

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

FDA NDC Directory listings under ANDA 090485
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-774
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-617
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-084
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7855
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0111
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Asclemed USA, Inc.	76420-983