Home NDC 63672-0021-9 Tamsulosin hydrochloride
Product NDC 63672-0021
Requested package NDC 63672-0021-9
11-digit product format 636720021
Labeler code 63672
Product ID 63672-0021_44e3098a-c374-d7aa-e063-6294a90aef5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tamsulosin hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Synthon Pharmaceuticals, Inc.
Application ANDA078801
Marketing category ANDA
Marketing start 2010-04-27
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 43 .
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 A078801-001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078801-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078801-001 TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE / ORAL AB 2010-04-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63672-0021-0 Tamsulosin hydrochloride 20200 in 1 DRUM CAPSULE 20200 7 63672-0021-9 Tamsulosin hydrochloride 20000 in 1 DRUM CAPSULE 20000 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded tamsulosin hydrochloride ACTIVE INGREDIENT 11SV1951MR TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 tamsulosin ACTIVE MOIETY G3P28OML5I TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 alcohol INACTIVE INGREDIENT 3K9958V90M TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 shellac INACTIVE INGREDIENT 46N107B71O TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63672-0021 TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250426_13a5032d-0be1-4001-916e-459f0b1a051d.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 · 3 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 63672-0021-9 63672002109 20000 CAPSULE in 1 DRUM (63672-0021-9) 20000 capsule 2024-01-15 No No Current