FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
68071-2561
11-digit product format
680712561
Labeler code
68071
Product ID
68071-2561_2dcc77bf-dfc5-3a63-e063-6394a90ad999
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
68071-2561-12025-02-10C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-32025-02-10C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-62025-02-10C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-92025-02-10C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-12025-01-30C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-32025-01-30C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-62025-01-30C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-92025-01-30C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-12023-07-17C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-32023-07-17C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-62023-07-17C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-92023-07-17C16284748780-1f386c649-e9aa-0266-e053-dadaa90a7c1aThese 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
68071-2561-1Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE103
68071-2561-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE303
68071-2561-6Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE603
68071-2561-9Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2561TAMSULOSIN HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 4 package rows20250212_cfd48327-a528-58cc-e053-2995a90a129f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNcfd48327-a528-58cc-e053-2995a90a129f3
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDcfd48327-a528-58cc-e053-2995a90a129f3
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYcfd48327-a528-58cc-e053-2995a90a129f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2561-16807125610110 CAPSULE in 1 BOTTLE (68071-2561-1) 10 capsule2021-11-020000-00-00NoNoCurrent
68071-2561-36807125610330 CAPSULE in 1 BOTTLE (68071-2561-3) 30 capsule2021-11-020000-00-00NoNoCurrent
68071-2561-66807125610660 CAPSULE in 1 BOTTLE (68071-2561-6) 60 capsule2021-11-020000-00-00NoNoCurrent
68071-2561-96807125610990 CAPSULE in 1 BOTTLE (68071-2561-9) 90 capsule2021-11-020000-00-00NoNoCurrent