Prescription drug · ANDA
Tramadol Hydrochloride NDC 71610-006
Tramadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-006-15 | 71610000615 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15)Marketed from Oct 6, 2017 | |
| 71610-006-20 | 71610000620 | 20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20)Marketed from Oct 6, 2017 | |
| 71610-006-24 | 71610000624 | 224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24)Marketed from Oct 6, 2017 | |
| 71610-006-28 | 71610000628 | 28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28)Marketed from Oct 6, 2017 | |
| 71610-006-30 | 71610000630 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30)Marketed from Oct 6, 2017 | |
| 71610-006-40 | 71610000640 | 40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40)Marketed from Oct 6, 2017 | |
| 71610-006-45 | 71610000645 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45)Marketed from Oct 6, 2017 | |
| 71610-006-46 | 71610000646 | 56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46)Marketed from Oct 6, 2017 | |
| 71610-006-48 | 71610000648 | 480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48)Marketed from Oct 6, 2017 | |
| 71610-006-50 | 71610000650 | 50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50)Marketed from Oct 6, 2017 | |
| 71610-006-53 | 71610000653 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53)Marketed from Oct 6, 2017 | |
| 71610-006-54 | 71610000654 | 84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54)Marketed from Oct 6, 2017 | |
| 71610-006-57 | 71610000657 | 80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57)Marketed from Aug 24, 2017 | |
| 71610-006-60 | 71610000660 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60)Marketed from Oct 6, 2017 | |
| 71610-006-65 | 71610000665 | 100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65)Marketed from Oct 6, 2017 | |
| 71610-006-67 | 71610000667 | 168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67)Marketed from Oct 6, 2017 | |
| 71610-006-70 | 71610000670 | 120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70)Marketed from Oct 6, 2017 | |
| 71610-006-72 | 71610000672 | 112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72)Marketed from Oct 6, 2017 | |
| 71610-006-73 | 71610000673 | 135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73)Marketed from Oct 6, 2017 | |
| 71610-006-75 | 71610000675 | 150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75)Marketed from Oct 6, 2017 | |
| 71610-006-80 | 71610000680 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80)Marketed from Oct 6, 2017 | |
| 71610-006-85 | 71610000685 | 200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85)Marketed from Oct 6, 2017 | |
| 71610-006-89 | 71610000689 | 720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89)Marketed from Oct 6, 2017 | |
| 71610-006-90 | 71610000690 | 240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90)Marketed from Oct 6, 2017 | |
| 71610-006-92 | 71610000692 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92)Marketed from Oct 6, 2017 | |
| 71610-006-94 | 71610000694 | 360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94)Marketed from Oct 6, 2017 | |
| 71610-006-98 | 71610000698 | 540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)Marketed from Oct 6, 2017 |
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
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075977
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71610-006_069eec8b-6cca-435c-9d3f-fbdc75a813a0SPL ID 069eec8b-6cca-435c-9d3f-fbdc75a813a0SPL set ID bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18eRxCUI 835603UNII 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
N471610000615followed by a unit qualifier and the quantityPackage 71610-0006-15. 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)
INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS ), reserve tramadol hydrochloride 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 are not expected to provide adequate analgesia.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075977
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 | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-3301 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-865 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-007 |