Prescription drug · NDA AUTHORIZED GENERIC
Tiagabine Hydrochloride NDC 0093-5030
Tiagabine hydrochloride 2 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5030-56 | 00093503056 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)Marketed from Jun 3, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tiagabine Hydrochloride
- Generic name (nonproprietary)
- tiagabine hydrochloride
- Active ingredients
- Tiagabine hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020646
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0093-5030_2a8d7987-54ae-45d7-8224-361dac37e0a4SPL ID 2a8d7987-54ae-45d7-8224-361dac37e0a4SPL set ID 953ef3cc-e3cb-480f-b9ea-256520fd62b8RxCUI 1299903, 1299909, 1299911, 1299917UNII DQH6T6D8OY
- Pharmacologic class
- Anti-epileptic Agent
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
N400093503056followed by a unit qualifier and the quantityPackage 00093-5030-56. 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)
INDICATIONS AND USAGE Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020646
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 |
|---|---|---|---|---|
| Tiagabine Hydrochloride | Tiagabine hydrochloride 4 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5031 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 12 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8072 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 16 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8076 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.