FDA.reportPublic FDA data

REYATAZ

Product NDC
0003-3624
11-digit product format
000033624
Labeler code
0003
Product ID
0003-3624_1cab2232-648a-4961-a179-30087315de3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATAZANAVIR
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA021567
Marketing category
NDA
Marketing start
2003-06-24
Marketing end
2023-04-30
Substance
ATAZANAVIR SULFATE
Active strength
150 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7bc938bd-f454-36ec-72ed-9ef05424b276Product name820221117
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-3624-12REYATAZ60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED6037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-3624-12EA - Each0003-362447ea6086-905b-4eee-9d72-db6d98996db812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATAZANAVIR SULFATEACTIVE INGREDIENT4MT4VIE29PREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
ATAZANAVIRACTIVE MOIETYQZU4H47A3SREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
ALCOHOLINACTIVE INGREDIENT3K9958V90MREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
AMMONIAINACTIVE INGREDIENT5138Q19F1XREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
CROSPOVIDONEINACTIVE INGREDIENT68401960MKREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
GELATININACTIVE INGREDIENT2G86QN327LREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
SHELLACINACTIVE INGREDIENT46N107B71OREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
SUCROSEINACTIVE INGREDIENTC151H8M554REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]22
ATAZANAVIR SULFATEACTIVE INGREDIENT4MT4VIE29PREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
ATAZANAVIRACTIVE MOIETYQZU4H47A3SREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREYATAZ (ATAZANAVIR SULFATE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-3624REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.]36Legacy NDC, 1 package rows20241220_165cff62-b284-4a27-a65d-9ec8a5bfcdd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598985atazanavir 50 MG Oral PowderPSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402246atazanavir sulfate 150 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402247atazanavir sulfate 200 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664741atazanavir sulfate 300 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402094Reyataz 150 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402093Reyataz 200 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664743Reyataz 300 MG Oral CapsulePSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598989Reyataz 50 MG Oral PowderPSN165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402094atazanavir 150 MG Oral Capsule [Reyataz]SBD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402093atazanavir 200 MG Oral Capsule [Reyataz]SBD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664743atazanavir 300 MG Oral Capsule [Reyataz]SBD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598989atazanavir 50 MG Oral Powder [Reyataz]SBD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402246atazanavir 150 MG Oral CapsuleSCD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402247atazanavir 200 MG Oral CapsuleSCD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664741atazanavir 300 MG Oral CapsuleSCD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598985atazanavir 50 MG Oral PowderSCD165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598989atazanavir (as atazanavir sulfate 56.9 MG) Oral Powder [Reyataz]SY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598985atazanavir 50 MG (as atazanavir sulfate 56.9 MG) Oral PowderSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402094Reyataz 150 MG Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402093Reyataz 200 MG Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
664743Reyataz 300 MG Oral CapsuleSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
1598989Reyataz 50 MG per packet Oral PowderSY165cff62-b284-4a27-a65d-9ec8a5bfcdd837
402246atazanavir sulfate 150 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
402247atazanavir sulfate 200 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
664741atazanavir sulfate 300 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
402094Reyataz 150 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
402093Reyataz 200 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
664743Reyataz 300 MG Oral CapsulePSN025876b6-f031-43ea-967a-b1d95b4685a62
402094atazanavir 150 MG Oral Capsule [Reyataz]SBD025876b6-f031-43ea-967a-b1d95b4685a62
402093atazanavir 200 MG Oral Capsule [Reyataz]SBD025876b6-f031-43ea-967a-b1d95b4685a62
664743atazanavir 300 MG Oral Capsule [Reyataz]SBD025876b6-f031-43ea-967a-b1d95b4685a62
402246atazanavir 150 MG Oral CapsuleSCD025876b6-f031-43ea-967a-b1d95b4685a62
402247atazanavir 200 MG Oral CapsuleSCD025876b6-f031-43ea-967a-b1d95b4685a62
664741atazanavir 300 MG Oral CapsuleSCD025876b6-f031-43ea-967a-b1d95b4685a62
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
402094Reyataz 150 MG Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
402093Reyataz 200 MG Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
664743Reyataz 300 MG Oral CapsuleSY025876b6-f031-43ea-967a-b1d95b4685a62
402246atazanavir sulfate 150 MG Oral CapsulePSN50ecd8f0-cb48-451c-839e-d59971a6695a1
402094Reyataz 150 MG Oral CapsulePSN50ecd8f0-cb48-451c-839e-d59971a6695a1
402094atazanavir 150 MG Oral Capsule [Reyataz]SBD50ecd8f0-cb48-451c-839e-d59971a6695a1
402246atazanavir 150 MG Oral CapsuleSCD50ecd8f0-cb48-451c-839e-d59971a6695a1
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY50ecd8f0-cb48-451c-839e-d59971a6695a1
402094Reyataz 150 MG Oral CapsuleSY50ecd8f0-cb48-451c-839e-d59971a6695a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-3624-120000336241260 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3624-12) 2003-06-242023-04-30NoNoCurrent