FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
62135-775
11-digit product format
621350775
Labeler code
62135
Product ID
62135-775_45adcea0-c5c1-9431-e063-6294a90a0471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207405
Marketing category
ANDA
Marketing start
2017-08-11
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-775-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
62135-775-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-775-30EA - Each62135-7750e8aca0a-485d-4cdd-8e0f-5a5f0fe51c1b12023-12-05
62135-775-90EA - Each62135-77530abf4e1-0472-4c34-a789-ed70751fced912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-775TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE) CAPSULE [CHARTWELL RX, LLC]3Current NDC, 2 package rows20231111_14db58df-7584-410b-8cf4-4b928dada859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN14db58df-7584-410b-8cf4-4b928dada8594
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD14db58df-7584-410b-8cf4-4b928dada8594
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY14db58df-7584-410b-8cf4-4b928dada8594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-775-306213507753030 CAPSULE in 1 BOTTLE (62135-775-30) 30 capsule2023-11-01NoNoCurrent
62135-775-906213507759090 CAPSULE in 1 BOTTLE (62135-775-90) 90 capsule2023-09-08NoNoCurrent