Home NDC 0115-8211-01 Tamsulosin Hydrochloride
Product NDC 0115-8211
Requested package NDC 0115-8211-01
11-digit product format 001158211
Labeler code 0115
Product ID 0115-8211_e62d078e-2896-4acd-bcaa-c21e855e66e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TAMSULOSIN HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA090377
Marketing category ANDA
Marketing start 2025-04-01
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 0115-8211-01 Tamsulosin Hydrochloride 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TAMSULOSIN HYDROCHLORIDE ACTIVE INGREDIENT 11SV1951MR TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 TAMSULOSIN ACTIVE MOIETY G3P28OML5I TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) INACTIVE INGREDIENT 5KY68S2577 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 SUCROSE INACTIVE INGREDIENT C151H8M554 TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 6 TAMSULOSIN HYDROCHLORIDE ACTIVE INGREDIENT 11SV1951MR TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 TAMSULOSIN ACTIVE MOIETY G3P28OML5I TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) INACTIVE INGREDIENT 5KY68S2577 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-8211 TAMSULOSIN HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 9 Current NDC, 1 package rows 20250419_c3ae55dd-6a0e-4f3a-82b6-2448e0545550.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 Sample Exclude flag Status 0115-8211-01 00115821101 100 CAPSULE in 1 BOTTLE (0115-8211-01) 100 capsule 2025-04-01 No No Current