FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
68788-7050
11-digit product format
687887050
Labeler code
68788
Product ID
68788-7050_574eb543-d5c6-4d15-a63c-7207e9d11745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202433
Marketing category
ANDA
Marketing start
2020-06-01
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
68788-7050-1Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1006
68788-7050-2Tamsulosin Hydrochloride20 in 1 BOTTLECAPSULE206
68788-7050-3Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE306
68788-7050-6Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE606
68788-7050-8Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1206
68788-7050-9Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7050-1EA - Each68788-7050f0946b22-75f5-4166-868d-52a05d5c560612024-04-05
68788-7050-2EA - Each68788-7050755d4bfe-2588-4b84-a721-0e21d1699bcf12024-04-05
68788-7050-3EA - Each68788-7050b6f73ca1-3ded-4850-9ca8-84b6a35bc5dd12024-04-05
68788-7050-6EA - Each68788-705050afe6e2-9688-413c-952a-ca82c3a3278f12024-04-05
68788-7050-8EA - Each68788-7050f58f89f3-8631-49d3-84a7-28f9e4094ded12024-04-05
68788-7050-9EA - Each68788-70508a347882-d0c2-413e-a3e5-45b51346b71512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7050TAMSULOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20240816_82d65964-de00-42c2-baaa-cc3de744b8eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD82d65964-de00-42c2-baaa-cc3de744b8eb6
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY82d65964-de00-42c2-baaa-cc3de744b8eb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7050-168788705001100 CAPSULE in 1 BOTTLE (68788-7050-1) 100 capsule2020-06-010000-00-00NoNoCurrent
68788-7050-26878870500220 CAPSULE in 1 BOTTLE (68788-7050-2) 20 capsule2020-06-010000-00-00NoNoCurrent
68788-7050-36878870500330 CAPSULE in 1 BOTTLE (68788-7050-3) 30 capsule2020-06-010000-00-00NoNoCurrent
68788-7050-66878870500660 CAPSULE in 1 BOTTLE (68788-7050-6) 60 capsule2020-06-010000-00-00NoNoCurrent
68788-7050-868788705008120 CAPSULE in 1 BOTTLE (68788-7050-8) 120 capsule2020-06-010000-00-00NoNoCurrent
68788-7050-96878870500990 CAPSULE in 1 BOTTLE (68788-7050-9) 90 capsule2020-06-010000-00-00NoNoCurrent