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RETROVIR

These highlights do not include all the information needed to use RETROVIR safely and effectively. See full prescribing information for RETROVIR.RETROVIR (zidovudine) capsules, for oral useRETROVIR (zidovudine) oral solutionRETROVIR (zidovudine) injection, for intravenous useInitial U.S. Approval: 1987

Approved
Approval ID

6df09f15-b102-431c-adde-d7aeef6f5d84

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 15, 2023

Manufacturers
FDA

ViiV Healthcare Company

DUNS: 027295585

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

zidovudine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49702-211
Application NumberNDA019655
Product Classification
M
Marketing Category
C73594
G
Generic Name
zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2020
FDA Product Classification

INGREDIENTS (11)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ZIDOVUDINEActive
Quantity: 100 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

zidovudine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49702-212
Application NumberNDA019910
Product Classification
M
Marketing Category
C73594
G
Generic Name
zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2020
FDA Product Classification

INGREDIENTS (6)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ZIDOVUDINEActive
Quantity: 10 mg in 1 mL
Code: 4B9XT59T7S
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

zidovudine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49702-213
Application NumberNDA019951
Product Classification
M
Marketing Category
C73594
G
Generic Name
zidovudine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 5, 2020
FDA Product Classification

INGREDIENTS (4)

ZIDOVUDINEActive
Quantity: 10 mg in 1 mL
Code: 4B9XT59T7S
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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RETROVIR - FDA Drug Approval Details