FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71610-835
11-digit product format
716100835
Labeler code
71610
Product ID
71610-835_199a74b0-47c0-012d-e063-6394a90ac375
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-835-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301
71610-835-53Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE601
71610-835-60Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-835-80Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-835-30EA - Each71610-835f5f7e020-6c3f-44be-8e9c-faf3f3d41f9c12024-07-12
71610-835-53EA - Each71610-8350273b3fd-6007-467a-a72c-5fb3717e6a3712024-07-12
71610-835-60EA - Each71610-8359c7e0112-17ef-4c37-984b-c9cc28db4eae12024-07-12
71610-835-80EA - Each71610-835df91ab90-0a39-4d62-8a70-616e04bb5ef812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-835TAMSULOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20240531_199a74b0-47bf-012d-e063-6394a90ac375.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN199a74b0-47bf-012d-e063-6394a90ac3751
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD199a74b0-47bf-012d-e063-6394a90ac3751
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY199a74b0-47bf-012d-e063-6394a90ac3751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-835-307161008353030 CAPSULE in 1 BOTTLE (71610-835-30) 30 capsule2024-05-24NoNoCurrent
71610-835-537161008355360 CAPSULE in 1 BOTTLE (71610-835-53) 60 capsule2024-05-24NoNoCurrent
71610-835-607161008356090 CAPSULE in 1 BOTTLE (71610-835-60) 90 capsule2024-05-24NoNoCurrent
71610-835-8071610083580180 CAPSULE in 1 BOTTLE (71610-835-80) 180 capsule2024-05-24NoNoCurrent