FDA.reportPublic FDA data

Atazanavir

Product NDC
31722-654
11-digit product format
317220654
Labeler code
31722
Product ID
31722-654_30891c38-5d64-7df7-e063-6394a90ae762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212278
Marketing category
ANDA
Marketing start
2022-02-07
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
31722-654-10Atazanavir1000 in 1 BOTTLECAPSULE10002
31722-654-31Atazanavir10 in 1 BLISTER PACKCAPSULE102
31722-654-31Atazanavir100 in 1 CARTONCAPSULE1002
31722-654-60Atazanavir60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-654-60EA - Each31722-6544715a7f1-90e8-4ba1-b63c-5b61d1fcdccf12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-654ATAZANAVIR (ATAZANAVIR) CAPSULE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 4 package rows20250319_8a0c609f-e296-4925-a35c-e93a04467655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402246atazanavir sulfate 150 MG Oral CapsulePSN8a0c609f-e296-4925-a35c-e93a044676552
402247atazanavir sulfate 200 MG Oral CapsulePSN8a0c609f-e296-4925-a35c-e93a044676552
664741atazanavir sulfate 300 MG Oral CapsulePSN8a0c609f-e296-4925-a35c-e93a044676552
402246atazanavir 150 MG Oral CapsuleSCD8a0c609f-e296-4925-a35c-e93a044676552
402247atazanavir 200 MG Oral CapsuleSCD8a0c609f-e296-4925-a35c-e93a044676552
664741atazanavir 300 MG Oral CapsuleSCD8a0c609f-e296-4925-a35c-e93a044676552
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY8a0c609f-e296-4925-a35c-e93a044676552
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY8a0c609f-e296-4925-a35c-e93a044676552
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY8a0c609f-e296-4925-a35c-e93a044676552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-654-10317220654101000 CAPSULE in 1 BOTTLE (31722-654-10) 1000 capsule2022-02-070000-00-00NoNoCurrent
31722-654-3131722065431100 BLISTER PACK in 1 CARTON (31722-654-31) / 10 CAPSULE in 1 BLISTER PACK100 blister pack2022-02-070000-00-00NoNoCurrent
31722-654-603172206546060 CAPSULE in 1 BOTTLE (31722-654-60) 60 capsule2022-02-070000-00-00NoNoCurrent