FDA.reportPublic FDA data

Zidovudine

Product NDC
31722-509
11-digit product format
317220509
Labeler code
31722
Product ID
31722-509_fbbb4305-5ef7-b4b5-e053-6294a90a278c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zidovudine
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA090092
Marketing category
ANDA
Marketing start
2008-04-25
Substance
ZIDOVUDINE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zidovudine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIDOVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B9XT59T7S
Rxcui199663

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
e1098f43-eafb-82a0-ef30-575f1d8189b0Product name220150227
9ceb457b-0c09-9326-bbca-f296202d412cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-509-602023-05-15C16284748780-1f386c64a-1347-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987
31722-509-602023-01-30C16284748780-1f386c64a-1347-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-509-60Zidovudine60 in 1 BOTTLETABLET605
31722-509-60Zidovudine12 in 1 CASETABLET125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-509-60EA - Each31722-509687ff579-e4b5-47bd-aba5-eeef56dd639012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-509ZIDOVUDINE (ZIDOVUDINE) TABLET [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20230517_ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199663zidovudine 300 MG Oral TabletPSNca9f0c57-fc8b-4da4-a987-0fc52b7fd4f45
199663zidovudine 300 MG Oral TabletSCDca9f0c57-fc8b-4da4-a987-0fc52b7fd4f45
199663AZT 300 MG Oral TabletSYca9f0c57-fc8b-4da4-a987-0fc52b7fd4f45
199663zidovudine 300 MG Oral TabletPSN437f55b2-f6d9-0065-e063-6294a90ab9292
199663zidovudine 300 MG Oral TabletSCD437f55b2-f6d9-0065-e063-6294a90ab9292
199663AZT 300 MG Oral TabletSY437f55b2-f6d9-0065-e063-6294a90ab9292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-509-603172205096012 BOTTLE in 1 CASE (31722-509-60) / 60 TABLET in 1 BOTTLE12 bottle2008-04-250000-00-00NoNoCurrent