FDA.reportPublic FDA data

NDC 51079-632-01 - Prazosin Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51079-632
Requested NDC
51079-632-01
Package NDCs from labels
51079-632-01, 51079-632-20
Manufacturer
Mylan Institutional Inc.
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prazosin Hydrochloride - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-632-01Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE112
51079-632-20Prazosin Hydrochloride100 in 1 CARTONCAPSULE10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-632PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20241010_e6a029b2-802f-4cc5-8795-20e177e8d779.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-632-01EA - Each51079-632d4b71472-478b-4d7b-9962-c678f7c5c5de12013-02-13
51079-632-20EA - Each51079-6328673a5d3-71a9-408e-b472-badda2c1fbe912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 176 · 3,515 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.e4852fc2-b763-40e2-b8bb-a3f6da5c72fe2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 198141
unii: X0Z7454B90
Prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.b55790fa-2413-4243-83ec-0391b2effe112026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 312594
unii: X0Z7454B90
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.