FDA.reportPublic FDA data

Irbesartan

Product NDC
33342-048
11-digit product format
333420048
Labeler code
33342
Product ID
33342-048_6838a6ad-aea4-4f3b-a3f8-466c76b41e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202254
Marketing category
ANDA
Marketing start
2012-09-27
Substance
IRBESARTAN
Active strength
150 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Irbesartan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRBESARTAN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200094, 200095, 200096

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-048-07Irbesartan30 in 1 BOTTLETABLET3012
33342-048-10Irbesartan90 in 1 BOTTLETABLET9012
33342-048-12Irbesartan10 in 1 BLISTER PACKTABLET1012
33342-048-12Irbesartan10 in 1 CARTONTABLET1012
33342-048-15Irbesartan500 in 1 BOTTLETABLET50012
33342-048-65Irbesartan6800 in 1 POUCHTABLET680012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-048-07EA - Each33342-0480e36caf3-923a-4950-8aae-7ee1561bf44b12013-02-13
33342-048-10EA - Each33342-048be40d3c4-9ed6-4025-ad82-8fdc77e6ee7f12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4IRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746IRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIRBESARTAN (IRBESARTAN ) TABLET IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-048IRBESARTAN TABLET [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 6 package rows20211014_e8635a1c-ae06-4e23-99f7-e704f91d6f43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSNe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200096irbesartan 300 MG Oral TabletPSNe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200094irbesartan 75 MG Oral TabletPSNe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200095irbesartan 150 MG Oral TabletSCDe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200096irbesartan 300 MG Oral TabletSCDe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200094irbesartan 75 MG Oral TabletSCDe8635a1c-ae06-4e23-99f7-e704f91d6f4312
200095irbesartan 150 MG Oral TabletPSNada35ec2-8472-411a-8e7c-ff1a0df94ab54
200095irbesartan 150 MG Oral TabletSCDada35ec2-8472-411a-8e7c-ff1a0df94ab54
200095irbesartan 150 MG Oral TabletPSNbc07bbf5-b1c6-4854-b6af-e06520c207283
200095irbesartan 150 MG Oral TabletSCDbc07bbf5-b1c6-4854-b6af-e06520c207283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-048-073334200480730 TABLET in 1 BOTTLE (33342-048-07) 30 tablet2012-09-270000-00-00NoNoCurrent
33342-048-103334200481090 TABLET in 1 BOTTLE (33342-048-10) 90 tablet2013-03-110000-00-00NoNoCurrent
33342-048-123334200481210 BLISTER PACK in 1 CARTON (33342-048-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2012-09-270000-00-00NoNoCurrent
33342-048-1533342004815500 TABLET in 1 BOTTLE (33342-048-15) 500 tablet2012-09-270000-00-00NoNoCurrent
33342-048-65333420048656800 TABLET in 1 POUCH (33342-048-65) 6800 tablet2019-02-260000-00-00NoNoCurrent