NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1144Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1144Add 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
70771-1144-070771114400707711144001000 CAPSULE in 1 BOTTLE (70771-1144-0)Marketed from Nov 22, 2017
70771-1144-17077111440170771114401100 CAPSULE in 1 BOTTLE (70771-1144-1)Marketed from Nov 22, 2017
70771-1144-57077111440570771114405500 CAPSULE in 1 BOTTLE (70771-1144-5)Marketed from Nov 22, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Zonisamide
Generic name (nonproprietary)
zonisamide
Active ingredients
Zonisamide — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077625
Marketing start
Listing expires
Other FDA classes
Carbonic Anhydrase Inhibitors (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)P-Glycoprotein Inhibitors (Mechanism)Sulfonamides (Chemical structure)
Identifiers
Product ID 70771-1144_1442d938-61eb-438e-b5be-900bda532050SPL ID 1442d938-61eb-438e-b5be-900bda532050
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

N470771114400 followed by a unit qualifier and the quantity

Package 70771-1144-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70771-1144

What is NDC 70771-1144?
70771-1144 is the product NDC for Zonisamide, Zonisamide 100 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zonisamide.
What is the active ingredient?
Zonisamide.
Who is the labeler?
Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zonisamide?
45 other product NDCs are listed under this name. See all Zonisamide 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 Zonisamide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZonisamideZonisamide 25 mg/1CapsuleOralREMEDYREPACK INC.70518-460070518-4600-0070518-4600-02
ZonisamideZonisamide 50 mg/1CapsuleOralREMEDYREPACK INC.70518-434970518-4349-00
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-62472189-0624-72
ZonisamideZonisamide 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-039280425-0392-0180425-0392-02
ZonisamideZonisamide 100 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-037080425-0370-01
ZonisamideZonisamide 100 mg/1CapsuleOralREMEDYREPACK INC.70518-390370518-3903-00
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-37472189-0374-72
ZonisamideZonisamide 100 mg/1CapsuleOralPreferred Pharmaceuticals Inc68788-400468788-4004-06
ZonisamideZonisamide 25 mg/1CapsuleOralBryant Ranch Prepack71335-279671335-2796-0171335-2796-0271335-2796-03+1 more
ZonisamideZonisamide 100 mg/1CapsuleOralBryant Ranch Prepack71335-279771335-2797-0171335-2797-0271335-2797-03+2 more

All 46 Zonisamide NDCs

Other NDCs under ANDA 077625

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

FDA NDC Directory listings under ANDA 077625
ProductStrengthForm · routeLabelerProduct NDC
ZonisamideZonisamide 100 mg/1CapsuleOralPreferred Pharmaceuticals Inc68788-4004
ZonisamideZonisamide 100 mg/1CapsuleOralREMEDYREPACK INC.70518-3903
ZonisamideZonisamide 25 mg/1CapsuleOralZydus Lifesciences Limited70771-1142
ZonisamideZonisamide 50 mg/1CapsuleOralZydus Lifesciences Limited70771-1143
ZonisamideZonisamide 25 mg/1CapsuleOralBryant Ranch Prepack71335-2796
ZonisamideZonisamide 100 mg/1CapsuleOralBryant Ranch Prepack71335-2797
ZonisamideZonisamide 25 mg/1CapsuleOralDirect_Rx72189-624
ZonisamideZonisamide 25 mg/1CapsuleOralViona Pharmaceuticals Inc72578-040
ZonisamideZonisamide 50 mg/1CapsuleOralViona Pharmaceuticals Inc72578-041
ZonisamideZonisamide 100 mg/1CapsuleOralViona Pharmaceuticals Inc72578-042
ZonisamideZonisamide 100 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0392

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