Prescription drug · ANDA
Tiagabine Hydrochloride NDC 62756-224
Tiagabine hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-224-08 | 62756022408 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)Marketed from Nov 4, 2011 | |
| 62756-224-18 | 62756022418 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)Marketed from Nov 4, 2011 | |
| 62756-224-83 | 62756022483 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)Marketed from Nov 4, 2011 | |
| 62756-224-88 | 62756022488 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)Marketed from Nov 4, 2011 |
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)
- Tiagabine Hydrochloride
- Generic name (nonproprietary)
- tiagabine hydrochloride
- Active ingredients
- Tiagabine hydrochloride — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077555
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62756-224_57975e74-e45b-4fd9-9718-bfc9690acae5SPL ID 57975e74-e45b-4fd9-9718-bfc9690acae5SPL set ID 7eeb2d81-c5d7-46a0-aa5c-149b55df71bdRxCUI 1299911, 1299917UNII DQH6T6D8OYUPC 0362756200838, 0362756224834
- 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
N462756022408followed by a unit qualifier and the quantityPackage 62756-0224-08. 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 hydrochloride tablets are 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.
About NDC 62756-224
- What is NDC 62756-224?
- 62756-224 is the product NDC for Tiagabine Hydrochloride, Tiagabine hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tiagabine Hydrochloride.
- What is the active ingredient?
- Tiagabine hydrochloride.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tiagabine Hydrochloride?
- 9 other product NDCs are listed under this name. See all Tiagabine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tiagabine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tiagabine Hydrochloride | Tiagabine hydrochloride 2 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-084 | 72205-0084-30 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 4 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-085 | 72205-0085-30 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 12 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-086 | 72205-0086-30 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 16 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-087 | 72205-0087-30 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 12 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8072 | 00093-8072-56 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 16 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-8076 | 00093-8076-56 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5030 | 00093-5030-56 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 4 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5031 | 00093-5031-56 |
| Tiagabine Hydrochloride | Tiagabine hydrochloride 2 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-200 | 62756-0200-1862756-0200-83 |
Other NDCs under ANDA 077555
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 2 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-200 |