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 61 of 108 · 2,159 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
unii: 15FIX9V2JP
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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