NDC codes

FDA NDC Directory
Product NDC (as listed)62756-224Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62756-0224Add 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
62756-224-0862756022408100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)Marketed from Nov 4, 2011
62756-224-18627560224181000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)Marketed from Nov 4, 2011
62756-224-836275602248330 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)Marketed from Nov 4, 2011
62756-224-8862756022488100 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

N462756022408 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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

Other Tiagabine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tiagabine HydrochlorideTiagabine hydrochloride 2 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-08472205-0084-30
Tiagabine HydrochlorideTiagabine hydrochloride 4 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-08572205-0085-30
Tiagabine HydrochlorideTiagabine hydrochloride 12 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-08672205-0086-30
Tiagabine HydrochlorideTiagabine hydrochloride 16 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-08772205-0087-30
Tiagabine HydrochlorideTiagabine hydrochloride 12 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-807200093-8072-56
Tiagabine HydrochlorideTiagabine hydrochloride 16 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-807600093-8076-56
Tiagabine HydrochlorideTiagabine hydrochloride 2 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-503000093-5030-56
Tiagabine HydrochlorideTiagabine hydrochloride 4 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-503100093-5031-56
Tiagabine HydrochlorideTiagabine hydrochloride 2 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-20062756-0200-1862756-0200-83

Other NDCs under ANDA 077555

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

FDA NDC Directory listings under ANDA 077555
ProductStrengthForm · routeLabelerProduct NDC
Tiagabine HydrochlorideTiagabine hydrochloride 2 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-200

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