VIGADRONE

Product NDC: 0245-0556
11-digit product format: 002450556
Labeler code: 0245
Product ID: 0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vigabatrin
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA210196
Marketing category: ANDA
Marketing start: 2018-06-21
Substance: VIGABATRIN
Active strength: 50 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: VIGADRONE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VIGABATRIN	50 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	GR120KRT6K
Rxcui	250820, 2047868

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
096748f0-965a-4afd-a326-9f691a2861e8	Product name	1	20250224
9dea3de0-6f03-9477-9f83-4ffb0883e43f	Product name	6	20240507
9a8c6108-e754-40ae-a629-36a466ae0079	Product name	8	20230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0245-0556-50	VIGADRONE	50 in 1 CARTON	POWDER, FOR SOLUTION	50		8
0245-0556-89	VIGADRONE	10 mL in 1 PACKET	POWDER, FOR SOLUTION	10		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0245-0556-50	EA - Each	0245-0556	8a6bbf50-2294-42b1-8c7c-b5c490f37c56	1	2018-07-03
0245-0556-89	EA - Each	0245-0556	9c1bd2de-2c00-4029-a1da-8992b2900ec0	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0245-0556	VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241121_5e5e7554-d0f4-47f7-a434-cc5ca5a9826f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
250820	vigabatrin 500 MG Powder for Oral Solution	PSN	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8
2047868	VIGADRONE 500 MG Powder for Oral Solution	PSN	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8
2047868	vigabatrin 500 MG Powder for Oral Solution [Vigadrone]	SBD	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8
250820	vigabatrin 500 MG Powder for Oral Solution	SCD	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8
2047868	Vigadrone 50 MG/ML (500 MG packet) Powder for Oral Solution	SY	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8
2047868	Vigadrone 500 MG Powder for Oral Solution	SY	5e5e7554-d0f4-47f7-a434-cc5ca5a9826f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0245-0556-50	00245055650	50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89)	50 packet	2018-06-21	0000-00-00	No	No	Current
0245-0556-89	00245055689	10 mL in 1 PACKET	10 ml					Historical