Home NDC 72865-350 tamsulosin hydrochloride
Product NDC 72865-350
11-digit product format 728650350
Labeler code 72865
Product ID 72865-350_9f4e621f-46a0-4d70-81cf-b6eb560383ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tamsulosin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler XLCare Pharmaceuticals, Inc.
Application ANDA214730
Marketing category ANDA
Marketing start 2026-01-01
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 2027-12-31
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 A214730-001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214730-001 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 2026-08-18 06:07:40 2026-07 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2022-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214730-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2022-05-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base tamsulosin hydrochloride
Listing expiration 2027-12-31 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 72865-350-05 tamsulosin hydrochloride 500 in 1 BOTTLE CAPSULE 500 1 72865-350-90 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 72865-350-05 72865035005 500 CAPSULE in 1 BOTTLE (72865-350-05) 500 capsule 2026-01-01 No No Current 72865-350-90 72865035090 90 CAPSULE in 1 BOTTLE (72865-350-90) 90 capsule 2026-01-01 No No Current