TAMSULOSIN HYDROCHLORIDE

Product NDC
64679-516
11-digit product format
646790516
Labeler code
64679
Product ID
64679-516_f5b0ae80-f386-4dbf-a01f-8f5b98e5a248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA078938
Marketing category
ANDA
Marketing start
2010-04-27
Marketing end
0000-00-00
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-516-02EA - Each64679-516b17c88d4-5312-4ec5-9759-c3186802391612012-07-24
64679-516-03EA - Each64679-5162bde3777-99e6-403e-a879-debacfbaab9912012-07-24
64679-516-04EA - Each64679-5166d009822-ad22-4579-912e-47a87c7fee5c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]3
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]2
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNaf558603-15f3-43e4-9ee5-9d38d59ef1c13
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDaf558603-15f3-43e4-9ee5-9d38d59ef1c13
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYaf558603-15f3-43e4-9ee5-9d38d59ef1c13
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa19b13a1-74a4-42da-80d1-d7c996445c262
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa19b13a1-74a4-42da-80d1-d7c996445c262
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa19b13a1-74a4-42da-80d1-d7c996445c262
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1ceb560b-1a62-408d-8e30-23113e8c9dd31
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa82c4269-b53d-4e7f-877a-88f0058266781
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf2bb56f9-0e60-4462-b17b-46b49638a8411
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1ceb560b-1a62-408d-8e30-23113e8c9dd31
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa82c4269-b53d-4e7f-877a-88f0058266781
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf2bb56f9-0e60-4462-b17b-46b49638a8411
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1ceb560b-1a62-408d-8e30-23113e8c9dd31
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa82c4269-b53d-4e7f-877a-88f0058266781
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf2bb56f9-0e60-4462-b17b-46b49638a8411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-516-0264679051602100 CAPSULE in 1 BOTTLE (64679-516-02) 100 capsule2010-04-270000-00-00NoNoCurrent
64679-516-0364679051603500 CAPSULE in 1 BOTTLE (64679-516-03) 500 capsule2010-04-270000-00-00NoNoCurrent