Home NDC 42291-989 Tamsulosin Hydrochloride
Product NDC 42291-989
11-digit product format 422910989
Labeler code 42291
Product ID 42291-989_43bec92e-7ee1-85d6-e063-6394a90a3167
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TAMSULOSIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA090377
Marketing category ANDA
Marketing start 2025-11-16
Substance TAMSULOSIN HYDROCHLORIDE
Active strength .4 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090377-001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090377-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090377-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-03-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tamsulosin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAMSULOSIN HYDROCHLORIDE .4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 11SV1951MR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863669 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 42291-989-10 Tamsulosin Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 1 42291-989-90 Tamsulosin Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
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 Sample Exclude flag Status 42291-989-10 42291098910 1000 CAPSULE in 1 BOTTLE (42291-989-10) 1000 capsule 2025-11-16 No No Current 42291-989-90 42291098990 90 CAPSULE in 1 BOTTLE (42291-989-90) 90 capsule 2025-11-16 No No Current