Home NDC 16252-539 Isradipine
Product NDC 16252-539
11-digit product format 162520539
Labeler code 16252
Product ID 16252-539_ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isradipine
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077317
Marketing category ANDA
Marketing start 2004-01-05
Substance ISRADIPINE
Active strength 2.5 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077317-001 ISRADIPINE ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 A077317-002 ISRADIPINE ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077317-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-01-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077317-002 ISRADIPINE 5MG CAPSULE / ORAL AB RS 2006-01-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isradipine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISRADIPINE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YO1UK1S598 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197848 Internal RxNorm lookup 197849 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16252-539-01 Isradipine 100 in 1 BOTTLE CAPSULE 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISRADIPINE ACTIVE INGREDIENT YO1UK1S598 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 ISRADIPINE ACTIVE MOIETY YO1UK1S598 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] 4 ISRADIPINE ACTIVE INGREDIENT YO1UK1S598 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 ISRADIPINE ACTIVE MOIETY YO1UK1S598 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ISRADIPINE (ISRADIPINE) CAPSULE [AVPAK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16252-539 ISRADIPINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20241122_bf3425e0-428d-4bdb-ac9a-3b9d483df83a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16252-539-01 16252053901 100 CAPSULE in 1 BOTTLE (16252-539-01) 100 capsule 2004-01-05 0000-00-00 No No Current