What is NDC 71335-0111?

71335-0111 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 Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Tramadol hydrochloride, Acetaminophen.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0111

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0111Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0111Add 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
71335-0111-1	71335011101	30 TABLET in 1 BOTTLE (71335-0111-1)Marketed from Mar 17, 2021
71335-0111-2	71335011102	60 TABLET in 1 BOTTLE (71335-0111-2)Marketed from Apr 14, 2021
71335-0111-3	71335011103	90 TABLET in 1 BOTTLE (71335-0111-3)Marketed from Aug 20, 2021
71335-0111-4	71335011104	120 TABLET in 1 BOTTLE (71335-0111-4)Marketed from Sep 26, 2022
71335-0111-5	71335011105	20 TABLET in 1 BOTTLE (71335-0111-5)Marketed from Apr 14, 2021
71335-0111-6	71335011106	40 TABLET in 1 BOTTLE (71335-0111-6)Marketed from Sep 26, 2022
71335-0111-7	71335011107	100 TABLET in 1 BOTTLE (71335-0111-7)Marketed from Sep 26, 2022
71335-0111-8	71335011108	15 TABLET in 1 BOTTLE (71335-0111-8)Marketed from Sep 26, 2022

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
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090485
Marketing start: Dec 17, 2009
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-0111_1c50d830-dc13-481d-b224-0260a6447d12SPL ID 1c50d830-dc13-481d-b224-0260a6447d12SPL set ID f33fcd05-2c95-48dd-884b-5ed9c25c2ccfRxCUI 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

N471335011101 followed by a unit qualifier and the quantity

Package 71335-0111-01. 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 Aug 30, 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 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 adequat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0111

What is NDC 71335-0111?: 71335-0111 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 Bryant Ranch Prepack. It has 8 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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	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

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	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	Asclemed USA, Inc.	76420-983
Tramadol/APAP	Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1	TabletOral	Direct_rx	72189-671