Gentamicin Sulfate Cream 0.1%

Product NDC: 70512-036
11-digit product format: 705120036
Labeler code: 70512
Product ID: 70512-036_a2b5d3ff-920e-280a-e053-2995a90ac84f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate Cream 0.1%
Dosage form: CREAM
Route: TOPICAL
Labeler: Sola Pharmaceuticals
Application: ANDA209304
Marketing category: ANDA
Marketing start: 2020-04-07
Marketing end: 0000-00-00
Substance: GENTAMICIN SULFATE
Active strength: 1 mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70512-036-30	2022-01-28	C162847	48780-1	d6a99b39-a2f9-a426-e053-dadaa90af4c2	a2b5d3ff-920d-280a-e053-2995a90ac84f

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70512-036-30	GM - Gram	70512-036	d657fe41-d0e7-47ea-8f8e-c6023c89ad6a	1	2020-07-13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8X7386QRLV	GENTAMICIN SULFATE	1405-41-0	GENTAMICIN SULFATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70512-036-30	70512003630	1 TUBE in 1 CARTON (70512-036-30) > 30 g in 1 TUBE	1 tube	2020-04-07	0000-00-00	No	No	Current