FDA.reportPublic FDA data

Atazanavir

Product NDC
42385-921
11-digit product format
423850921
Labeler code
42385
Product ID
42385-921_0e18774c-a32c-4961-9684-f5c6ffce64a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA212579
Marketing category
ANDA
Marketing start
2021-04-30
Substance
ATAZANAVIR SULFATE
Active strength
200 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATAZANAVIR SULFATE200 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
42385-921-06Atazanavir6 in 1 BLISTER PACKCAPSULE64
42385-921-48Atazanavir10 in 1 CARTONCAPSULE104
42385-921-60Atazanavir60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-921-60EA - Each42385-921d7e4ce87-e2df-4de4-9933-57ec95dcb31812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-921ATAZANAVIR CAPSULE [LAURUS LABS LIMITED]3Current NDC, Legacy NDC, 3 package rows20240407_c98e40ec-8a2c-4f19-b1c3-c82f708c2490.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402246atazanavir sulfate 150 MG Oral CapsulePSNc98e40ec-8a2c-4f19-b1c3-c82f708c24904
402247atazanavir sulfate 200 MG Oral CapsulePSNc98e40ec-8a2c-4f19-b1c3-c82f708c24904
664741atazanavir sulfate 300 MG Oral CapsulePSNc98e40ec-8a2c-4f19-b1c3-c82f708c24904
402246atazanavir 150 MG Oral CapsuleSCDc98e40ec-8a2c-4f19-b1c3-c82f708c24904
402247atazanavir 200 MG Oral CapsuleSCDc98e40ec-8a2c-4f19-b1c3-c82f708c24904
664741atazanavir 300 MG Oral CapsuleSCDc98e40ec-8a2c-4f19-b1c3-c82f708c24904
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSYc98e40ec-8a2c-4f19-b1c3-c82f708c24904
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSYc98e40ec-8a2c-4f19-b1c3-c82f708c24904
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSYc98e40ec-8a2c-4f19-b1c3-c82f708c24904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42385-921-06423850921066 in 1 BLISTER PACKHistorical
42385-921-484238509214810 BLISTER PACK in 1 CARTON (42385-921-48) / 6 CAPSULE in 1 BLISTER PACK (42385-921-06) 10 blister pack2021-04-300000-00-00NoNoCurrent
42385-921-604238509216060 CAPSULE in 1 BOTTLE (42385-921-60) 60 capsule2021-04-300000-00-00NoNoCurrent