FDA.reportPublic FDA data

Atazanavir Sulfate

Product NDC
0093-5528
11-digit product format
000935528
Labeler code
0093
Product ID
0093-5528_61209ea1-63c7-43fc-ac32-d840a8a0906a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir Sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091673
Marketing category
ANDA
Marketing start
2017-12-27
Substance
ATAZANAVIR SULFATE
Active strength
300 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 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
Atazanavir Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATAZANAVIR SULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4MT4VIE29P
Rxcui402246, 402247, 664741

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7bc938bd-f454-36ec-72ed-9ef05424b276Product name820221117
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5528-56Atazanavir Sulfate30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5528-56EA - Each0093-552820092115-eb0c-40da-a215-401583adbe4f12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5528ATAZANAVIR SULFATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 1 package rows20250403_654b7e08-33d8-47e7-b37f-3681e79c7b8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402246atazanavir sulfate 150 MG Oral CapsulePSN654b7e08-33d8-47e7-b37f-3681e79c7b8b14
402247atazanavir sulfate 200 MG Oral CapsulePSN654b7e08-33d8-47e7-b37f-3681e79c7b8b14
664741atazanavir sulfate 300 MG Oral CapsulePSN654b7e08-33d8-47e7-b37f-3681e79c7b8b14
402246atazanavir 150 MG Oral CapsuleSCD654b7e08-33d8-47e7-b37f-3681e79c7b8b14
402247atazanavir 200 MG Oral CapsuleSCD654b7e08-33d8-47e7-b37f-3681e79c7b8b14
664741atazanavir 300 MG Oral CapsuleSCD654b7e08-33d8-47e7-b37f-3681e79c7b8b14
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY654b7e08-33d8-47e7-b37f-3681e79c7b8b14
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY654b7e08-33d8-47e7-b37f-3681e79c7b8b14
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY654b7e08-33d8-47e7-b37f-3681e79c7b8b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5528-560009355285630 CAPSULE in 1 BOTTLE (0093-5528-56) 30 capsule2017-12-270000-00-00NoNoCurrent