What is NDC 72189-382?

72189-382 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 tablet, film coated, 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 Hydrochloride and Acetaminophen?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tramadol Hydrochloride and Acetaminophen NDC 72189-382

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-382Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0382Add 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
72189-382-60	7218903826072189038260	60 TABLET, FILM COATED in 1 BOTTLE (72189-382-60)Marketed from Sep 14, 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): Tramadol Hydrochloride and Acetaminophen
Generic name (nonproprietary): tramadol hydrochloride and acetaminophen
Active ingredients: Acetaminophen — 325 mg/1Tramadol hydrochloride — 37.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207152
Marketing start: Sep 14, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-382_2c4cd58a-0293-714d-e063-6394a90a5eddSPL ID 2c4cd58a-0293-714d-e063-6394a90a5eddSPL set ID e8a7c995-e473-ca87-e053-2995a90a5b80RxCUI 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

N472189038260 followed by a unit qualifier and the quantity

Package 72189-0382-60. 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 Jan 22, 2025.

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, even at recommended doses [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 analgesia, or ar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-382

What is NDC 72189-382?: 72189-382 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 tablet, film coated, 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 Hydrochloride and Acetaminophen.
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 Hydrochloride and Acetaminophen?: 14 other product NDCs are listed under this name. See all Tramadol Hydrochloride and Acetaminophen 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 Tramadol Hydrochloride and Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4461	70518-4461-00
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-922	60760-0922-20
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7855	68788-7855-0268788-7855-0368788-7855-09
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-170	45865-0170-60
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-922	65862-0922-0165862-0922-0565862-0922-30+2 more
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-625	71205-0625-3071205-0625-6071205-0625-90
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1742	71335-1742-0171335-1742-0271335-1742-03+5 more
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2510	72162-2510-01
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-774	50268-0774-15
Tramadol Hydrochloride And Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-105	76420-0105-0176420-0105-0276420-0105-03+2 more

All 15 Tramadol Hydrochloride and Acetaminophen NDCs

Other NDCs under ANDA 207152

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

FDA NDC Directory listings under ANDA 207152
Product	Strength	Form · route	Labeler	Product NDC
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-170
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-922
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-922
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4461
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-625
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1742
Tramadol Hydrochloride and Acetaminophen	Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2510