FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
70518-0179
11-digit product format
705180179
Labeler code
70518
Product ID
70518-0179_4a789dc3-f07a-112c-e063-6294a90a16c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202433
Marketing category
ANDA
Marketing start
2017-01-26
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0179-0Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE3018
70518-0179-1Tamsulosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE9018
70518-0179-2Tamsulosin Hydrochloride28 in 1 BLISTER PACKCAPSULE2818
70518-0179-3Tamsulosin Hydrochloride100 in 1 BOXCAPSULE10018
70518-0179-4Tamsulosin Hydrochloride1 in 1 POUCHCAPSULE118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNb30e2bde-b20e-4899-a100-f44170d8165b18
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDb30e2bde-b20e-4899-a100-f44170d8165b18
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYb30e2bde-b20e-4899-a100-f44170d8165b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0179-07051801790030 CAPSULE in 1 BLISTER PACK (70518-0179-0) 30 capsule2017-01-260000-00-00NoNoCurrent
70518-0179-17051801790190 CAPSULE in 1 BOTTLE, PLASTIC (70518-0179-1) 90 capsule2017-01-310000-00-00NoNoCurrent
70518-0179-27051801790228 in 1 BLISTER PACKHistorical
70518-0179-370518017903100 POUCH in 1 BOX (70518-0179-3) / 1 CAPSULE in 1 POUCH (70518-0179-4) 100 pouch2026-02-10NoNoHistorical
70518-0179-4705180179041 in 1 POUCHHistorical