FDA.reportPublic FDA data

NDC 68071-5259-04 - Doxycycline Hyclate

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
68071-5259
Requested NDC
68071-5259-04
Package NDCs from labels
68071-5259-2, 68071-5259-4, 68071-5259-04
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxycycline Hyclate - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5259-22022-02-07C16284748780-1d6a99b39-3db5-a426-e053-dadaa90af4c2Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
68071-5259-22022-01-28C16284748780-1d6a99b39-3db5-a426-e053-dadaa90af4c2Doxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5259-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE204
68071-5259-4Doxycycline Hyclate14 in 1 BOTTLECAPSULE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5259DOXYCYCLINE HYCLATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_a5f02688-cbba-4d9b-e053-2995a90ad1ba.zip

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 222 of 277 · 5,535 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shimmy Original Hand SanitizerALCOHOLShimmy Products LLCc4c135ed-3b6a-69c8-e053-2a95a90aad1c2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Rose Hibiscus Hand SanitizerALCOHOLShimmy Products LLCc50b5044-31fd-672a-e053-2995a90a49fc2024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Meyer Lemon Hand SanitizerALCOHOLShimmy Products LLCc50b9543-e276-9052-e053-2a95a90a83252024-07-25WarningsExact identifier
unii: 3K9958V90M
Shimmy Neutral Hand SanitizerALCOHOLShimmy Products LLCdf2761b9-0fca-5e2a-e053-2a95a90a9b8d2024-07-25WarningsExact identifier
unii: 3K9958V90M
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.bcab4842-50ff-4c7f-8b85-0126f4b585b02024-07-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Altra Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2974445-eaa3-d9f0-e053-2995a90a78fc2024-07-23WarningsExact identifier
unii: 3K9958V90M
LAVENDER SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.5c27f212-4010-44de-9e9d-758ffdfcc5c12024-07-18WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Incb3c59433-a4cd-42cb-9492-fcdc19ca765c2024-07-18WarningsExact identifier
unii: 3K9958V90M
COCONUT SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.2fa53710-c084-48e0-8300-511d0d93a88d2024-07-18WarningsExact identifier
unii: 3K9958V90M
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.a5f02688-cbba-4d9b-e053-2995a90ad1ba2024-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA062500
ndc (package): 68071-5259-2
ndc (package): 68071-5259-4
ndc (product): 68071-5259
ndc11 (package): 68071525904
rxcui: 1649988
spl id: 1d78c398-adb9-0cd1-e063-6394a90ab75d
spl set id: a5f02688-cbba-4d9b-e053-2995a90ad1ba
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.a707c9e3-00eb-e832-e053-2a95a90a5f582024-07-17Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
unii: 15FIX9V2JP
b.pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.bc35f9ec-e453-4994-91ae-2294d058e45d2024-07-12WarningsExact identifier
unii: 3K9958V90M
b.pure Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df2024-07-12WarningsExact identifier
unii: 3K9958V90M
b.pure Hand Sanitizer Green Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.7c870d8f-c298-4469-b6d1-f318f6adfd262024-07-12WarningsExact identifier
unii: 3K9958V90M
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
unii: 15FIX9V2JP
Ecolab FaciliproALCOHOLEcolab Inc.87aa66da-bbc7-4d02-851b-63c19e68578a2024-07-12WarningsExact identifier
unii: 3K9958V90M
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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