What is NDC 0093-8076?

0093-8076 is the product NDC for Tiagabine Hydrochloride, Tiagabine hydrochloride 16 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tiagabine Hydrochloride NDC 0093-8076 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-8076Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-8076Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0093-8076-56	00093807656	30 TABLET, FILM COATED in 1 BOTTLE (0093-8076-56)Marketed from Mar 9, 2018

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 — 16 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020646
Marketing start: Mar 9, 2018
Marketing end: Oct 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0093-8076_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

N400093807656 followed by a unit qualifier and the quantity

Package 00093-8076-56. 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 Sep 30, 2021.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0093-8076

What is NDC 0093-8076?: 0093-8076 is the product NDC for Tiagabine Hydrochloride, Tiagabine hydrochloride 16 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, 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?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tiagabine Hydrochloride NDCs
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 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
Tiagabine Hydrochloride	Tiagabine hydrochloride 4 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	62756-224	62756-0224-0862756-0224-1862756-0224-83+1 more

Other NDCs under NDA 020646

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020646
Product	Strength	Form · route	Labeler	Product NDC
Tiagabine Hydrochloride	Tiagabine hydrochloride 2 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-5030
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