FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50268-740
Requested package NDC
50268-740-15
11-digit product format
502680740
Labeler code
50268
Product ID
50268-740_41c4deb3-2dcf-b17a-e063-6294a90ad2be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA207405
Marketing category
ANDA
Marketing start
2018-01-17
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207405-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207405-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207405-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2017-08-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207405-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEChartwell RX, LLC14db58df-7584-410b-8cf4-4b928dada8592025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAvPAK62fa7fdf-c588-6f79-e053-2a91aa0a4c192025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
ndc (package): 50268-740-15
ndc (product): 50268-740
ndc11 (package): 50268074015
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEGolden State Medical Supply, Inc.18e9741b-969a-5a87-e063-6294a90a88512025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackf185abfc-367d-45da-87c4-86d9f70bcd5d2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAscend Laboratories, LLCed9988bc-0759-4c36-bee1-11b68dc1c84c2025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions3a05970e-6c34-4dff-9fd7-dde8ce60f2802023-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions74a8ef78-908f-4671-91a3-ec3a044aabf22023-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEProficient Rx LP06b44e53-c6e7-4e12-a8fd-572d092cfa702020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207405
application number: ANDA207405

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11SV1951MRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
863669Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62fa7fdf-c588-6f79-e053-2a91aa0a4c19Available on FDA.report

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
50268-740-01Tamsulosin Hydrochloride100 in 1 BOXCAPSULE10011
50268-740-11Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE111
50268-740-15Tamsulosin Hydrochloride50 in 1 BOX, UNIT-DOSECAPSULE5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-740-01EA - Each50268-740d2dc1b0d-b70e-4428-9a17-07a2740186d712025-12-16
50268-740-11EA - Each50268-740b6c8c492-bbd4-4677-80fb-c2a061bdfda112018-03-08
50268-740-15EA - Each50268-740354ae719-106e-422f-afe3-78645693680b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-740TAMSULOSIN HYDROCHLORIDE CAPSULE [AVPAK]10Current NDC, Legacy NDC, 3 package rows20240110_62fa7fdf-c588-6f79-e053-2a91aa0a4c19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1e044a8a-c3ee-defc-e063-6394a90a60611
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1e044a8a-c3ee-defc-e063-6394a90a60611
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1e044a8a-c3ee-defc-e063-6394a90a60611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-740-155026807401550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-740-15) / 1 CAPSULE in 1 BLISTER PACK (50268-740-11) 50 blister pack2018-01-170000-00-00NoNoCurrent