Prescription drug · ANDA
Tramadol Hydrochloride NDC 68788-4114
Tramadol hydrochloride 50 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4114-1 | 68788411401 | 90 TABLET in 1 BOTTLE (68788-4114-1)Marketed from Jun 8, 2026 | |
| 68788-4114-2 | 68788411402 | 20 TABLET in 1 BOTTLE (68788-4114-2)Marketed from Jun 8, 2026 | |
| 68788-4114-3 | 68788411403 | 30 TABLET in 1 BOTTLE (68788-4114-3)Marketed from Jun 8, 2026 | |
| 68788-4114-4 | 68788411404 | 40 TABLET in 1 BOTTLE (68788-4114-4)Marketed from Jun 8, 2026 | |
| 68788-4114-5 | 68788411405 | 15 TABLET in 1 BOTTLE (68788-4114-5)Marketed from Jun 8, 2026 | |
| 68788-4114-6 | 68788411406 | 50 TABLET in 1 BOTTLE (68788-4114-6)Marketed from Jun 8, 2026 | |
| 68788-4114-8 | 68788411408 | 100 TABLET in 1 BOTTLE (68788-4114-8)Marketed from Jun 8, 2026 | |
| 68788-4114-9 | 68788411409 | 60 TABLET in 1 BOTTLE (68788-4114-9)Marketed from Jun 8, 2026 |
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
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075968
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68788-4114_855905c7-1481-4b2d-a318-3254ad8ed73cSPL ID 855905c7-1481-4b2d-a318-3254ad8ed73cSPL set ID 855905c7-1481-4b2d-a318-3254ad8ed73cRxCUI 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
N468788411401followed by a unit qualifier and the quantityPackage 68788-4114-01. 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 tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride tablets are an opioid agonist indicated in adults f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075968
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 | TabletOral | Rising Pharma Holdings, Inc. | 64980-614 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-663 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3147 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-727 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0588 |