FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
62756-160
11-digit product format
627560160
Labeler code
62756
Product ID
62756-160_52595417-3e2e-4d58-9167-dd5b2bf1b082
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090931
Marketing category
ANDA
Marketing start
2010-07-15
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-160-08Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10013
62756-160-13Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE50013
62756-160-18Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE100013
62756-160-81Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9013
62756-160-83Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3013
62756-160-88Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-160-13EA - Each62756-1605756e053-f5b6-47eb-8d47-2d169b79ba6612012-07-24
62756-160-81EA - Each62756-16088bde4d9-e3e5-4f83-afb3-6af2010eaa7b12012-07-24
62756-160-88EA - Each62756-1603be3fb9e-ff61-46a2-8086-4bd1a39e2b4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)INACTIVE INGREDIENT24P2YXD2PWTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-160TAMSULOSIN HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 6 package rows20210101_d742707b-4c17-4b08-a9d0-491ba2bf6415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNd742707b-4c17-4b08-a9d0-491ba2bf641513
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDd742707b-4c17-4b08-a9d0-491ba2bf641513
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYd742707b-4c17-4b08-a9d0-491ba2bf641513
863669tamsulosin HCl 0.4 MG Oral CapsulePSN48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin HCl 0.4 MG Oral CapsulePSN49245aec-9a0f-459e-e054-00144ff8d46c4
863669tamsulosin HCl 0.4 MG Oral CapsulePSNbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD49245aec-9a0f-459e-e054-00144ff8d46c4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY48f57acf-24de-4415-8c42-f8c3260917044
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY49245aec-9a0f-459e-e054-00144ff8d46c4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYbf583b4a-a99c-4e18-a6d1-8609b5db1a3a4
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf423f79c-09c9-b071-e053-2995a90aedfd2
863669tamsulosin HCl 0.4 MG Oral CapsulePSN94dc4410-ef44-4e4c-ace3-8595397215402
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf423f79c-09c9-b071-e053-2995a90aedfd2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD94dc4410-ef44-4e4c-ace3-8595397215402
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY94dc4410-ef44-4e4c-ace3-8595397215402
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf423f79c-09c9-b071-e053-2995a90aedfd2
863669tamsulosin HCl 0.4 MG Oral CapsulePSNebf2996d-7094-d5a3-e053-2995a90a3af01
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1d845218-1562-42a2-98fe-3b13cd5d05421
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDebf2996d-7094-d5a3-e053-2995a90a3af01
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1d845218-1562-42a2-98fe-3b13cd5d05421
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1d845218-1562-42a2-98fe-3b13cd5d05421
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYebf2996d-7094-d5a3-e053-2995a90a3af01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-160-0862756016008100 CAPSULE in 1 BOTTLE (62756-160-08) 100 capsule2010-07-150000-00-00NoNoCurrent
62756-160-1362756016013500 CAPSULE in 1 BOTTLE (62756-160-13) 500 capsule2010-07-150000-00-00NoNoCurrent
62756-160-18627560160181000 CAPSULE in 1 BOTTLE (62756-160-18) 1000 capsule2010-07-150000-00-00NoNoCurrent
62756-160-816275601608190 CAPSULE in 1 BOTTLE (62756-160-81) 90 capsule2010-07-150000-00-00NoNoCurrent
62756-160-836275601608330 CAPSULE in 1 BOTTLE (62756-160-83) 30 capsule2010-07-150000-00-00NoNoCurrent
62756-160-8862756016088100 CAPSULE in 1 BOTTLE (62756-160-88) 100 capsule2010-07-150000-00-00NoNoCurrent