Prescription drug · ANDA
Tramadol Hydrochloride and Acetaminophen NDC 72189-382
Acetaminophen 325 mg/1; Tramadol hydrochloride 37.5 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-382-60 | 72189038260 | 60 TABLET, FILM COATED in 1 BOTTLE (72189-382-60)Marketed from Sep 14, 2022 |
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
- Acetaminophen — 325 mg/1Tramadol hydrochloride — 37.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_Rx
- 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 72189-382_2c4cd58a-0293-714d-e063-6394a90a5eddSPL ID 2c4cd58a-0293-714d-e063-6394a90a5eddSPL set ID e8a7c995-e473-ca87-e053-2995a90a5b80RxCUI 836395UNII 362O9ITL9D, 9N7R477WCK
- 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
N472189038260followed by a unit qualifier and the quantityPackage 72189-0382-60. 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 .
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, even at recommended doses [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 adequate analgesia, or ar…
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 | Tramadol hydrochloride 37.5 mg/1; Acetaminophen 325 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1742 |