NDC codes

FDA NDC Directory
Product NDC (as listed)0093-5030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-5030Add 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 NDC11-digit (billing)PackageCopy
0093-5030-560009350305630 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 hydrochloride2 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

N400093503056 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
Tiagabine HydrochlorideTiagabine hydrochloride 4 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-5031
Tiagabine HydrochlorideTiagabine hydrochloride 12 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-8072
Tiagabine HydrochlorideTiagabine hydrochloride 16 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-8076

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