NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1654Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1654Add 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
70771-1654-170771165401100 TABLET, FILM COATED in 1 BOTTLE (70771-1654-1)Marketed from Jan 20, 2022

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)
vigabatrin
Generic name (nonproprietary)
vigabatrin
Active ingredients
Vigabatrin500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215707
Marketing start
Listing expires
Identifiers
Product ID 70771-1654_5eea977c-802f-4fdf-9ad3-70a4e2f1cf1dSPL ID 5eea977c-802f-4fdf-9ad3-70a4e2f1cf1dSPL set ID e9c99000-fc0c-4083-b620-ba9ac821f8acRxCUI 199521UNII GR120KRT6K
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

N470771165401 followed by a unit qualifier and the quantity

Package 70771-1654-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent ( 1.1 ) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions ( 5.1 )] . Vigabatrin tablets are not indicated as

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215707

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

FDA NDC Directory listings under ANDA 215707
ProductStrengthForm · routeLabelerProduct NDC
vigabatrinVigabatrin 500 mg/1Tablet, Film coatedOralZydus Pharmaceuticals (USA) Inc.70710-1287

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in