Ciprofloxacin and Fluocinolone Acetonide

Product NDC: 52536-080
11-digit product format: 525360080
Labeler code: 52536
Product ID: 52536-080_902d710e-3983-4f9b-b8eb-4a990bc4efa8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ciprofloxacin and fluocinolone acetonide
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Wilshire Pharmaceuticals
Application: NDA208251
Marketing category: NDA
Marketing start: 2019-11-01
Marketing end: 0000-00-00
Substance: CIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active strength: 1 mg/.25mL; mg/.25mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
52536-080-14	2024-03-05	C162847	48780-1	d6a99b39-50da-a426-e053-dadaa90af4c2	7841d7d6-e950-4956-a0a2-4381c90cfe34
52536-080-14	2022-01-28	C162847	48780-1	d6a99b39-50da-a426-e053-dadaa90af4c2	7841d7d6-e950-4956-a0a2-4381c90cfe34

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-080-14	EA - Each	52536-080	190238f8-a234-4475-9598-59107fec4a99	1	2019-12-10

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5E8K9I0O4U	CIPROFLOXACIN	85721-33-1	CIPROFLOXACIN
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52536-080-14	52536008014	1 POUCH in 1 CARTON (52536-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE	1 pouch	2019-11-01	0000-00-00	No	No	Current