What is NDC 45865-170?

45865-170 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 tablet, film coated, listed with the FDA by Medsource Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Tramadol hydrochloride, Acetaminophen.

Medsource Pharmaceuticals, NDC labeler code 45865. 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 45865-170

NDC codes

FDA NDC Directory

Product NDC (as listed)45865-170Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45865-0170Add 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
45865-170-60	4586501706045865017060	60 TABLET, FILM COATED in 1 BOTTLE (45865-170-60)Marketed from Mar 8, 2021

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, Film coated
Route: Oral
Labeler: Medsource PharmaceuticalsNDC labeler code 45865
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 45865-170_12f113b3-d6b2-a7b0-e063-6294a90a999dSPL ID 12f113b3-d6b2-a7b0-e063-6294a90a999dSPL set ID 12f113b3-d6b1-a7b0-e063-6294a90a999dRxCUI 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

N445865017060 followed by a unit qualifier and the quantity

Package 45865-0170-60. 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 Mar 5, 2024. 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 hydrochlorideandacetaminophen 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 orare not expected to be tolerated, Have not provided adequate a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45865-170

What is NDC 45865-170?: 45865-170 is the product NDC for Tramadol Hydrochloride and Acetaminophen, Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 tablet, film coated, listed with the FDA by Medsource Pharmaceuticals. 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?: Tramadol hydrochloride, Acetaminophen.
Who is the labeler?: Medsource Pharmaceuticals, NDC labeler code 45865. 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	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	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
Tramadol Hydrochloride and Acetaminophen	Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-382