FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
68999-626
11-digit product format
689990626
Labeler code
68999
Product ID
68999-626_40076faf-09c3-f4ab-e063-6394a90ab3c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC
Application
ANDA062505
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O, 19XTS3T51U
Rxcui1649405, 1649988, 1650030, 1650143, 1652674

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-626-02Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2010
68999-626-05Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED50010
68999-626-06Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED10010
68999-626-10Doxycycline Hyclate1000 in 1 BOTTLETABLET, FILM COATED100010
68999-626-12Doxycycline Hyclate120 in 1 BOTTLETABLET, FILM COATED12010
68999-626-23Doxycycline Hyclate210 in 1 BOTTLETABLET, FILM COATED21010
68999-626-28Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2810
68999-626-30Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED3010
68999-626-31Doxycycline Hyclate300 in 1 BOTTLETABLET, FILM COATED30010
68999-626-40Doxycycline Hyclate400 in 1 BOTTLETABLET, FILM COATED40010
68999-626-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED5010
68999-626-96Doxycycline Hyclate2000 in 1 BOTTLETABLET, FILM COATED200010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [CHARTWELL GOVERNMENTAL AND SPECIALTY RX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68999-626DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL GOVERNMENTAL & SPECIALTY RX, LLC]9Current NDC, Legacy NDC, 12 package rows20230719_b8486639-7eb9-4610-9cd4-0e922045d592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNb8486639-7eb9-4610-9cd4-0e922045d59210
1650143doxycycline hyclate 100 MG Oral TabletPSNb8486639-7eb9-4610-9cd4-0e922045d59210
1649405doxycycline hyclate 50 MG Oral CapsulePSNb8486639-7eb9-4610-9cd4-0e922045d59210
1652674doxycycline hyclate 50 MG Oral TabletPSNb8486639-7eb9-4610-9cd4-0e922045d59210
1650030doxycycline monohydrate 25 MG in 5 mL Oral SuspensionPSNb8486639-7eb9-4610-9cd4-0e922045d59210
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb8486639-7eb9-4610-9cd4-0e922045d59210
1650143doxycycline hyclate 100 MG Oral TabletSCDb8486639-7eb9-4610-9cd4-0e922045d59210
1649405doxycycline hyclate 50 MG Oral CapsuleSCDb8486639-7eb9-4610-9cd4-0e922045d59210
1652674doxycycline hyclate 50 MG Oral TabletSCDb8486639-7eb9-4610-9cd4-0e922045d59210
1650030doxycycline monohydrate 5 MG/ML Oral SuspensionSCDb8486639-7eb9-4610-9cd4-0e922045d59210
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb8486639-7eb9-4610-9cd4-0e922045d59210
1650030doxycycline monohydrate 25 MG per 5 ML Oral SuspensionSYb8486639-7eb9-4610-9cd4-0e922045d59210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68999-626-026899906260220 TABLET, FILM COATED in 1 BOTTLE (68999-626-02) 2022-06-240000-00-00NoNoCurrent
68999-626-0568999062605500 TABLET, FILM COATED in 1 BOTTLE (68999-626-05) 2025-09-17NoNoHistorical
68999-626-0668999062606100 TABLET, FILM COATED in 1 BOTTLE (68999-626-06) 2022-06-240000-00-00NoNoCurrent
68999-626-10689990626101000 TABLET, FILM COATED in 1 BOTTLE (68999-626-10) 2021-09-01NoNoHistorical
68999-626-1268999062612120 TABLET, FILM COATED in 1 BOTTLE (68999-626-12) 2025-09-17NoNoHistorical
68999-626-2368999062623210 TABLET, FILM COATED in 1 BOTTLE (68999-626-23) 2021-09-010000-00-00NoNoCurrent
68999-626-286899906262828 TABLET, FILM COATED in 1 BOTTLE (68999-626-28) 2021-09-010000-00-00NoNoCurrent
68999-626-306899906263030 TABLET, FILM COATED in 1 BOTTLE (68999-626-30) 2021-11-120000-00-00NoNoCurrent
68999-626-3168999062631300 TABLET, FILM COATED in 1 BOTTLE (68999-626-31) 2021-09-010000-00-00NoNoCurrent
68999-626-4068999062640400 TABLET, FILM COATED in 1 BOTTLE (68999-626-40) 2021-09-010000-00-00NoNoCurrent
68999-626-506899906265050 TABLET, FILM COATED in 1 BOTTLE (68999-626-50) 2021-09-010000-00-00NoNoCurrent
68999-626-96689990626962000 TABLET, FILM COATED in 1 BOTTLE (68999-626-96) 2025-09-170000-00-00NoNoCurrent