FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
68071-4443
11-digit product format
680714443
Labeler code
68071
Product ID
68071-4443_1a8cbdda-6567-1230-e063-6394a90a5083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4443-12023-03-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-32023-03-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-62023-03-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-92023-03-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-12023-01-30C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-32023-01-30C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-62023-01-30C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-92023-01-30C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-12021-02-16C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-32021-02-16C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-62021-02-16C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-92021-02-16C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-12021-01-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-32021-01-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-62021-01-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-92021-01-29C16284748780-1ba0f9c33-114c-a910-e053-dadaa90a0b85These 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
68071-4443-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE107
68071-4443-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE307
68071-4443-6Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE607
68071-4443-9Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4443TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20240612_6cb939a6-2bc6-5ca0-e053-2991aa0a4e69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD6cb939a6-2bc6-5ca0-e053-2991aa0a4e697
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY6cb939a6-2bc6-5ca0-e053-2991aa0a4e697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4443-16807144430110 CAPSULE in 1 BOTTLE (68071-4443-1) 10 capsule2018-05-210000-00-00NoNoCurrent
68071-4443-36807144430330 CAPSULE in 1 BOTTLE (68071-4443-3) 30 capsule2018-05-210000-00-00NoNoCurrent
68071-4443-66807144430660 CAPSULE in 1 BOTTLE (68071-4443-6) 60 capsule2018-05-210000-00-00NoNoCurrent
68071-4443-96807144430990 CAPSULE in 1 BOTTLE (68071-4443-9) 90 capsule2018-05-210000-00-00NoNoCurrent