What is NDC 53746-617?

53746-617 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Tramadol hydrochloride, Acetaminophen.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 53746-617

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-617Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0617Add 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
53746-617-01	53746061701	100 TABLET in 1 BOTTLE (53746-617-01)Marketed from Dec 17, 2009
53746-617-05	53746061705	500 TABLET in 1 BOTTLE (53746-617-05)Marketed from Dec 17, 2009
53746-617-10	53746061710	1000 TABLET in 1 BOTTLE (53746-617-10)Marketed from Dec 17, 2009
53746-617-30	53746061730	30 TABLET in 1 BOTTLE (53746-617-30)Marketed from Dec 17, 2009

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: Tramadol hydrochloride — 37.5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090485
Marketing start: Dec 17, 2009
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 53746-617_90386181-256c-422d-8f7e-1bf0959b69bbSPL ID 90386181-256c-422d-8f7e-1bf0959b69bbSPL set ID d51600e2-2f73-483c-9b2e-f142bafff16dRxCUI 836395UNII 9N7R477WCK, 362O9ITL9DUPC 0353746617309
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

N453746061701 followed by a unit qualifier and the quantity

Package 53746-0617-01. 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 Jan 1, 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including tramadol hydrochloride and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-617

What is NDC 53746-617?: 53746-617 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tramadol Hydrochloride and Acetaminophen.
What is the active ingredient?: Tramadol hydrochloride, Acetaminophen.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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	Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-382	72189-0382-60
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	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	72162-2510	72162-2510-01
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	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	TabletOral	AvPAK	50268-774	50268-0774-15

All 15 Tramadol Hydrochloride and Acetaminophen NDCs

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	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/APAP	Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1	TabletOral	Direct_rx	72189-671
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	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