Tramadol Hydrochloride and Acetaminophen NDC 72162-2510

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-2510Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-2510Add 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
72162-2510-1	72162251001	100 TABLET, FILM COATED in 1 BOTTLE (72162-2510-1)Marketed from Mar 22, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207152
Marketing start: Mar 22, 2017
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72162-2510_c303c3cf-8061-4da4-9d7b-f3a819e660c3SPL ID c303c3cf-8061-4da4-9d7b-f3a819e660c3SPL set ID c83366d9-db60-45eb-9c2b-a2c58d45c82cRxCUI 836395UNII 9N7R477WCK, 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

N472162251001 followed by a unit qualifier and the quantity

Package 72162-2510-01. 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 Mar 13, 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 ot…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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	REMEDYREPACK INC.	70518-4461
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	Proficient Rx LP	71205-625
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	Bryant Ranch Prepack	71335-1742
Tramadol Hydrochloride and Acetaminophen	Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-382