What is NDC 70771-1078?

70771-1078 is the product NDC for Felbamate, Felbamate 600 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

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 Felbamate?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Felbamate NDC 70771-1078 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1078Add 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
70771-1078-1	7077110780170771107801	100 TABLET in 1 BOTTLE (70771-1078-1)Marketed from Aug 15, 2017
70771-1078-3	7077110780370771107803	30 TABLET in 1 BOTTLE (70771-1078-3)Marketed from Aug 15, 2017
70771-1078-4	7077110780470771107804	10 BLISTER PACK in 1 CARTON (70771-1078-4) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 15, 2017
70771-1078-5	7077110780570771107805	500 TABLET in 1 BOTTLE (70771-1078-5)Marketed from Aug 15, 2017
70771-1078-8	7077110780870771107808	180 TABLET in 1 BOTTLE (70771-1078-8)Marketed from Aug 15, 2017
70771-1078-9	7077110780970771107809	90 TABLET in 1 BOTTLE (70771-1078-9)Marketed from Aug 15, 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): Felbamate
Generic name (nonproprietary): felbamate
Active ingredients: Felbamate — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208970
Marketing start: Aug 15, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 70771-1078_785f1747-e29d-432a-82e7-fcaeea202327SPL ID 785f1747-e29d-432a-82e7-fcaeea202327SPL set ID efa55cb2-b625-4392-9ddb-0a8ad8ee58c4RxCUI 198358, 198359UNII X72RBB02N8
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

N470771107801 followed by a unit qualifier and the quantity

Package 70771-1078-01. 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 Aug 16, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1078

What is NDC 70771-1078?: 70771-1078 is the product NDC for Felbamate, Felbamate 600 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Felbamate.
What is the active ingredient?: Felbamate.
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 Felbamate?: 19 other product NDCs are listed under this name. See all Felbamate 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 Felbamate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Felbamate	Felbamate 400 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-734	53746-0734-3053746-0734-90
Felbamate	Felbamate 600 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-735	53746-0735-1853746-0735-3053746-0735-90
Felbamate	Felbamate 600 mg/5mL	SuspensionOral	Novitium Pharma LLC	70954-051	70954-0051-1070954-0051-20
Felbamate	Felbamate 400 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-056	72578-0056-0172578-0056-0572578-0056-06+2 more
Felbamate	Felbamate 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-057	72578-0057-0172578-0057-0572578-0057-06+3 more
Felbamate	Felbamate 400 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-730	62559-0730-01
Felbamate	Felbamate 600 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-731	62559-0731-01
Felbamate	Felbamate 400 mg/1	TabletOral	Bryant Ranch Prepack	63629-1937	63629-1937-01
Felbamate	Felbamate 600 mg/1	TabletOral	Bryant Ranch Prepack	63629-1944	63629-1944-01
Felbamate	Felbamate 400 mg/1	TabletOral	Bryant Ranch Prepack	72162-1770	72162-1770-01

All 20 Felbamate NDCs

Other NDCs under ANDA 208970

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

FDA NDC Directory listings under ANDA 208970
Product	Strength	Form · route	Labeler	Product NDC
Felbamate	Felbamate 400 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1077
Felbamate	Felbamate 400 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-056
Felbamate	Felbamate 600 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-057