FDA.reportPublic FDA data

Atazanavir Sulfate

Product NDC
65862-710
11-digit product format
658620710
Labeler code
65862
Product ID
65862-710_8f8c56e0-40ee-4643-88f7-d3571ff5a409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204806
Marketing category
ANDA
Marketing start
2018-06-25
Substance
ATAZANAVIR SULFATE
Active strength
100 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 SULFATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4MT4VIE29P
Rxcui402245, 402246, 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
65862-710-03Atazanavir Sulfate3 in 1 CARTONCAPSULE38
65862-710-05Atazanavir Sulfate500 in 1 BOTTLECAPSULE5008
65862-710-10Atazanavir Sulfate10 in 1 BLISTER PACKCAPSULE108
65862-710-60Atazanavir Sulfate60 in 1 BOTTLECAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-710ATAZANAVIR SULFATE (ATAZANAVIR) CAPSULE [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 4 package rows20250206_7fbea274-d6b5-4faa-bbf0-05fefab42114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402245atazanavir sulfate 100 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir sulfate 150 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir sulfate 200 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir sulfate 300 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402245atazanavir 100 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir 150 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir 200 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir 300 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402245atazanavir 100 MG (as atazanavir sulfate 113.9 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-710-03658620710033 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10) 3 blister pack2018-06-250000-00-00NoNoCurrent
65862-710-0565862071005500 CAPSULE in 1 BOTTLE (65862-710-05) 500 capsule2018-06-250000-00-00NoNoCurrent
65862-710-106586207101010 in 1 BLISTER PACKHistorical
65862-710-606586207106060 CAPSULE in 1 BOTTLE (65862-710-60) 60 capsule2018-06-250000-00-00NoNoCurrent