FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
43063-947
11-digit product format
430630947
Labeler code
43063
Product ID
43063-947_415ef20a-0a9b-ddbc-e063-6294a90acdcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-947-30Tamsulosin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3022
43063-947-90Tamsulosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-947-30EA - Each43063-947a4ae1c25-39ac-43c6-bed5-49e5253c451412019-05-02
43063-947-90EA - Each43063-9473033de9a-181e-41b5-b3e0-e3d1736cdf0e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-947TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20241018_f6b6aeab-bedd-4254-8811-4f65cf8a351f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf6b6aeab-bedd-4254-8811-4f65cf8a351f22
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf6b6aeab-bedd-4254-8811-4f65cf8a351f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-947-304306309473030 CAPSULE in 1 BOTTLE, PLASTIC (43063-947-30) 30 capsule2019-04-050000-00-00NoNoCurrent
43063-947-904306309479090 CAPSULE in 1 BOTTLE, PLASTIC (43063-947-90) 90 capsule2019-02-140000-00-00NoNoCurrent