FDA.reportPublic FDA data

Tamsulosin hydrochloride

Product NDC
63672-0021
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

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63672-0021-02023-11-02C16284748780-1956f9ecf-d82a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE capsules. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
63672-0021-02019-10-21C16284748780-1956f9ecf-d82a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE capsules. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-0021-0Tamsulosin hydrochloride20200 in 1 DRUMCAPSULE202007
63672-0021-9Tamsulosin hydrochloride20000 in 1 DRUMCAPSULE200007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tamsulosin hydrochlorideACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
tamsulosinACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
shellacINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-0021TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250426_13a5032d-0be1-4001-916e-459f0b1a051d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN13a5032d-0be1-4001-916e-459f0b1a051d7
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD13a5032d-0be1-4001-916e-459f0b1a051d7
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY13a5032d-0be1-4001-916e-459f0b1a051d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63672-0021-06367200210020200 in 1 DRUMHistorical
63672-0021-96367200210920000 CAPSULE in 1 DRUM (63672-0021-9) 20000 capsule2024-01-15NoNoHistorical