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 74 of 281 · 5,610 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsExact identifier
unii: 3K9958V90M
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack6e06e73c-b777-4a2d-988f-b009f2fc34d12026-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA062500
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepackb70a3a12-76a2-4558-bf2c-eaa38a9ba0a02026-01-27Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
DOXYCYCLINEDOXYCYCLINEJVET PHARMACEUTICALS LLCed95709e-2a1a-4deb-88bd-5b99f02b7a262026-01-27Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.49455156-1072-14f5-e063-6294a90abdff2026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Instant Hand Sanitizer Wipes with Aloe VeraALCOHOLLiving Better Brands LLCcf4b671f-697a-47d3-921e-2de4330739182026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Advanced Hand Sanitizer with Aloe VeraALCOHOLLiving Better Brands LLCcbf0fead-0729-460b-82c0-1596c995cf2b2026-01-26WarningsExact identifier
unii: 3K9958V90M
Signature Select Advanced Hand SanitizerALCOHOLLiving Better Brands LLC6d1cc25b-d612-4aae-bdb0-304758ef8f0f2026-01-26WarningsExact identifier
unii: 3K9958V90M
Homworks Alcohol Wipes MultipurposeETHYL ALCOHOLAcadian Crossing Consumer Products, LLC.c9f0c3b3-5f39-dfa6-e053-2995a90a76442026-01-26WarningsExact identifier
unii: 3K9958V90M
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
unii: 15FIX9V2JP
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack6f530f28-8c10-41dc-818f-1aef2306bde52026-01-26Warnings, Adverse reactionsExact identifier
application number: ANDA062500
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATERedPharm Drug, Inc.bdacaaa7-b46e-ee0c-e053-2a95a90aea3c2026-01-23Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Juniper Clean Hand SanitizerALCOHOLKYNC Design LLCa6bb7f88-ac9b-4f72-e053-2995a90ac15c2026-01-23WarningsExact identifier
unii: 3K9958V90M
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
unii: 15FIX9V2JP
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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