Prescription drug · ANDA
Tramadol Hydrochloride and Acetaminophen NDC 70518-4461
Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70518-4461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4461Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4461-0 | 7051844610070518446100 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4461-0)Marketed from Aug 28, 2025 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-4461_5b37cc89-fb6a-9098-e063-6394a90a721eSPL ID 5b37cc89-fb6a-9098-e063-6394a90a721e
- 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
N470518446100followed by a unit qualifier and the quantityPackage 70518-4461-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4461
- What is NDC 70518-4461?
- 70518-4461 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 REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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.
Related NDCs: other Tramadol Hydrochloride and Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 |
| 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 |
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 | Medsource Pharmaceuticals | 45865-170 |
| 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 | 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 |