Home NDC 23155-977 nisoldipine
Product NDC 23155-977
11-digit product format 231550977
Labeler code 23155
Product ID 23155-977_cef2c469-9a1b-46f3-b08f-57ea2876311f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nisoldipine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA216606
Marketing category ANDA
Marketing start 2026-08-01
Substance NISOLDIPINE
Active strength 17 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216606-001 NISOLDIPINE NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 A216606-002 NISOLDIPINE NISOLDIPINE 17MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216606-001 AB
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.
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 2026-09-14 22:38:34 2026-08 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216606-002 NISOLDIPINE 17MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216606-002 NISOLDIPINE 17MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216606-002 NISOLDIPINE 17MG TABLET, EXTENDED RELEASE / ORAL AB 2025-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL 2023-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216606-001 NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE / ORAL AB 2023-04-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216606-002 NISOLDIPINE 17MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base nisoldipine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NISOLDIPINE 17 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4I8HAB65SZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 763519 Internal RxNorm lookup 790489 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join nisoldipine NISOLDIPINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. a52b773a-44f9-442f-a4be-39f79a558bd2 2026-06-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216606 application number: ANDA216606 ndc (product): 23155-977
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 23155-977-01 23155097701 1 BOTTLE in 1 CARTON (23155-977-01) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2026-08-01 No No Current