FDA.reportPublic FDA data

NDC 54868-4249-2 - Terazosin 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
54868-4249
Requested NDC
54868-4249-2
Package NDCs from labels
54868-4249-0, 54868-4249-1, 54868-4249-3, 54868-4249-4, 54868-4249-5, 54868-4249-2
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terazosin Hydrochloride CapsulesPhysicians Total Care, Inc.2013-02-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
54868-4249-0Terazosin Hydrochloride Capsules
54868-4249-1Terazosin Hydrochloride Capsules
54868-4249-3Terazosin Hydrochloride Capsules
54868-4249-4Terazosin Hydrochloride Capsules
54868-4249-5Terazosin Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4249-0Terazosin Hydrochloride30 in 1 BOTTLECAPSULE306
54868-4249-1Terazosin Hydrochloride100 in 1 BOTTLECAPSULE1006
54868-4249-3Terazosin Hydrochloride60 in 1 BOTTLECAPSULE606
54868-4249-4Terazosin Hydrochloride90 in 1 BOTTLECAPSULE906
54868-4249-5Terazosin Hydrochloride180 in 1 BOTTLECAPSULE1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4249TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]65 package rows20130225_88ac2dc1-062f-42c4-93ba-8a09116dbaed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-4249-0EA - Each54868-4249f7116765-ae65-4905-9a77-3cfb4a9ee1fc12012-07-24
54868-4249-1EA - Each54868-42494fbc8d10-7e29-4510-971f-8d9d5c6217f412012-07-24
54868-4249-2EA - Each54868-4249e72785c4-939b-47dd-8e1f-06b563b671f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]6

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 90 of 108 · 2,159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerazosinTERAZOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC85e450c2-1bc3-49f4-ac2b-5aeedc154bba2024-02-01Warnings, Adverse reactionsExact identifier
rxcui: 260376
unii: D32S14F082
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: 15FIX9V2JP
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: 15FIX9V2JP
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
unii: 15FIX9V2JP
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: 15FIX9V2JP
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
unii: 15FIX9V2JP
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
unii: 15FIX9V2JP
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 15FIX9V2JP
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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