Prescription drug · ANDA
Tramadol Hydrochloride and Acetaminophen NDC 71335-1742
Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1742-1 | 71335174201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1742-1)Marketed from Dec 28, 2020 | |
| 71335-1742-2 | 71335174202 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1742-2)Marketed from Jan 26, 2021 | |
| 71335-1742-3 | 71335174203 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1742-3)Marketed from Mar 5, 2021 | |
| 71335-1742-4 | 71335174204 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1742-4)Marketed from Mar 8, 2023 | |
| 71335-1742-5 | 71335174205 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1742-5)Marketed from May 3, 2023 | |
| 71335-1742-6 | 71335174206 | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1742-6)Marketed from Apr 5, 2024 | |
| 71335-1742-7 | 71335174207 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1742-7)Marketed from Apr 5, 2024 | |
| 71335-1742-8 | 71335174208 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1742-8)Marketed from Apr 5, 2024 |
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
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-1742_c3c5af52-f6d0-43f9-8adf-c046a433c4dbSPL ID c3c5af52-f6d0-43f9-8adf-c046a433c4dbSPL set ID ccf465b5-8ef8-4445-a0d4-23b5cf13188cRxCUI 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
N471335174201followed by a unit qualifier and the quantityPackage 71335-1742-01. 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 . 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.
Other NDCs under ANDA 207152
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Bryant Ranch Prepack | 72162-2510 |
| 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 | Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-382 |