Tamsulosin Hydrochloride

Product NDC
42291-989
11-digit product format
422910989
Labeler code
42291
Product ID
42291-989_43bec92e-7ee1-85d6-e063-6394a90a3167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA090377
Marketing category
ANDA
Marketing start
2025-11-16
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-989-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10001
42291-989-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-989-10EA - Each42291-98945d8b31b-cad5-403f-8d96-350519b15c4b12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN43bec742-fbc4-39af-e063-6294a90ac7341
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD43bec742-fbc4-39af-e063-6294a90ac7341
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY43bec742-fbc4-39af-e063-6294a90ac7341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-989-10422910989101000 CAPSULE in 1 BOTTLE (42291-989-10) 1000 capsule2025-11-16NoNoCurrent
42291-989-904229109899090 CAPSULE in 1 BOTTLE (42291-989-90) 90 capsule2025-11-16NoNoCurrent