FDA.reportPublic FDA data

TAMSULOSIN HYDROCHLORIDE

Product NDC
61919-703
11-digit product format
619190703
Labeler code
61919
Product ID
61919-703_4f5b9312-d5df-2068-e063-6294a90abad0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202433
Marketing category
ANDA
Marketing start
2019-07-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TAMSULOSIN HYDROCHLORIDE
Listing expiration
2027-12-31

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
61919-703-302025-01-30C16284748780-12cef2736-8b98-d83d-e063-dadaa90ab31fTAMSULOSIN HYDROCHLORIDE
61919-703-302025-01-30C16284748780-12cef2736-8b98-d83d-e063-dadaa90ab31fTAMSULOSIN HYDROCHLORIDE
61919-703-902025-01-30C16284748780-12cef2736-a607-d83d-e063-dadaa90ab31fTAMSULOSIN HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-703-30TAMSULOSIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE304
61919-703-90TAMSULOSIN HYDROCHLORIDE90 in 1 CAPSULECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-703TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20221007_8de50eca-8cc5-082d-e053-2a95a90a346d.zip
61919-703TAMSULOSIN HYDROCHLORIDE CAPSULE [DIRECT RX]1Current NDC, Legacy NDC, 1 package rows20190119_7a420aca-31e6-8e0c-e053-2a91aa0a1be0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY8de50eca-8cc5-082d-e053-2a95a90a346d4
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7a420aca-31e6-8e0c-e053-2a91aa0a1be02
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7a420aca-31e6-8e0c-e053-2a91aa0a1be02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-703-306191907033030 CAPSULE in 1 BOTTLE (61919-703-30) 30 capsule2019-07-170000-00-00NoNoCurrent
61919-703-906191907039090 CAPSULE in 1 CAPSULE (61919-703-90) 90 capsule2018-11-090000-00-00NoNoCurrent