Zidovudine

Product NDC: 53104-0100
11-digit product format: 531040100
Labeler code: 53104
Product ID: 53104-0100_412da56b-a627-40fa-a943-900540bdd9ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zidovudine
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla Ltd.
Application: ANDA078349
Marketing category: ANDA
Marketing start: 2007-05-23
Marketing end: 0000-00-00
Substance: ZIDOVUDINE
Active strength: 100 mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53104-0100-4	2025-12-23	C162847	48780-1	9d75b9d0-d423-f424-e053-dadaa90a57ce	536735fc-566c-4ad4-b83e-602199ff82b4
53104-0100-6	2025-12-23	C162847	48780-1	9d75b9d0-d423-f424-e053-dadaa90a57ce	536735fc-566c-4ad4-b83e-602199ff82b4
53104-0100-4	2020-01-31	C162847	48780-1	9d75b9d0-d423-f424-e053-dadaa90a57ce	536735fc-566c-4ad4-b83e-602199ff82b4
53104-0100-6	2020-01-31	C162847	48780-1	9d75b9d0-d423-f424-e053-dadaa90a57ce	536735fc-566c-4ad4-b83e-602199ff82b4

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53104-0100	ZIDOVUDINE CAPSULE [CIPLA LTD.]	13	Legacy NDC	20181130_536735fc-566c-4ad4-b83e-602199ff82b4.zip