Synalar

Product NDC: 43538-901
11-digit product format: 435380901
Labeler code: 43538
Product ID: 43538-901_f11341ca-d1fb-499d-82b7-923d1ab1dab8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone acetonide
Dosage form: KIT
Route: TOPICAL
Labeler: Medimetriks Pharmaceuticals, Inc.
Application: NDA012787
Marketing category: NDA
Marketing start: 2012-12-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43538-901-12	2023-12-08	C162847	48780-1	0191ceaa-6b3c-198a-e063-dbdaa90aec3e	SYNALAR ® (fluocinolone acetonide) Cream, 0.025%
43538-901-12	2023-07-28	C162847	48780-1	0191ceaa-6b3c-198a-e063-dbdaa90aec3e	SYNALAR ® (fluocinolone acetonide) Cream, 0.025%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43538-901-12	GM - Gram	43538-901	3ee8238f-ebc4-487a-8bcf-14a4efabd15f	1	2013-03-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43538-901-12	43538090112	1 KIT in 1 CARTON (43538-901-12) * 255 g in 1 TUBE * 1 TUBE in 1 CARTON > 120 g in 1 TUBE	1 kit	2012-12-15	0000-00-00	No	No	Current