Home NDC 0615-7607 Tamsulosin Hydrochloride
Product NDC 0615-7607
11-digit product format 006157607
Labeler code 0615
Product ID 0615-7607_484d179f-c1d7-4b8e-a3df-d22ece88e497
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tamsulosin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA090408
Marketing category ANDA
Marketing start 2010-04-29
Marketing end 0000-00-00
Substance TAMSULOSIN HYDROCHLORIDE
Active strength 0 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 52 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7607-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7607-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7607-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7607-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7607-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7607-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7607-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7607-05 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7607-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7607-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7607-05 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7607-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7607-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7607-05 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7607-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7607-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7607-05 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7607-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7607-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7607-05 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7607-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7607-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7607-05 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7607-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7607-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7607-05 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7607-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7607-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7607-05 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7607-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7607-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7607-05 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7607-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7607-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7607-05 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7607-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7607-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7607-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7607-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A090408-001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27
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 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090408-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL 2010-04-27 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TAMSULOSIN HYDROCHLORIDE ACTIVE INGREDIENT 11SV1951MR TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 TAMSULOSIN ACTIVE MOIETY G3P28OML5I TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6