FDA.reportPublic FDA data

Irbesartan

Product NDC
29300-212
11-digit product format
293000212
Labeler code
29300
Product ID
29300-212_90c9face-5ead-4f4e-81f3-026124b50ba8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA203020
Marketing category
ANDA
Marketing start
2015-12-07
Substance
IRBESARTAN
Active strength
75 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
IRBESARTAN75 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
29300-212-05Irbesartan500 in 1 BOTTLE, PLASTICTABLET50013
29300-212-13Irbesartan30 in 1 BOTTLE, PLASTICTABLET3013
29300-212-19Irbesartan90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-212-13EA - Each29300-2126c1ff921-37e7-42bf-b839-1b266a2b57b412024-02-14
29300-212-19EA - Each29300-2122000f089-6296-4211-aef8-15f8e1ade01812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-212IRBESARTAN TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]12Current NDC, Legacy NDC, 3 package rows20220120_fdf196d5-e933-49de-9c4c-bde50149c7d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200095irbesartan 150 MG Oral TabletPSNfdf196d5-e933-49de-9c4c-bde50149c7d413
200096irbesartan 300 MG Oral TabletPSNfdf196d5-e933-49de-9c4c-bde50149c7d413
200094irbesartan 75 MG Oral TabletPSNfdf196d5-e933-49de-9c4c-bde50149c7d413
200095irbesartan 150 MG Oral TabletSCDfdf196d5-e933-49de-9c4c-bde50149c7d413
200096irbesartan 300 MG Oral TabletSCDfdf196d5-e933-49de-9c4c-bde50149c7d413
200094irbesartan 75 MG Oral TabletSCDfdf196d5-e933-49de-9c4c-bde50149c7d413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-212-0529300021205500 TABLET in 1 BOTTLE, PLASTIC (29300-212-05) 500 tablet2018-02-280000-00-00NoNoCurrent
29300-212-132930002121330 TABLET in 1 BOTTLE, PLASTIC (29300-212-13) 30 tablet2018-02-280000-00-00NoNoCurrent
29300-212-192930002121990 TABLET in 1 BOTTLE, PLASTIC (29300-212-19) 90 tablet2018-02-280000-00-00NoNoCurrent