doxycycline hyclate

Product NDC
68999-985
11-digit product format
689990985
Labeler code
68999
Product ID
68999-985_40076faf-09c3-f4ab-e063-6394a90ab3c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC
Application
ANDA062500
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
Unii19XTS3T51U, N12000U13O
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
68999-985-01doxycycline hyclate100 in 1 BOTTLECAPSULE10010
68999-985-05doxycycline hyclate500 in 1 BOTTLECAPSULE50010
68999-985-10doxycycline hyclate1000 in 1 BOTTLECAPSULE100010
68999-985-50doxycycline hyclate50 in 1 BOTTLECAPSULE5010

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
68999-985DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL GOVERNMENTAL & SPECIALTY RX, LLC]9Current NDC, Legacy NDC, 4 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68999-985-0168999098501100 CAPSULE in 1 BOTTLE (68999-985-01) 100 capsule2025-09-17NoNoCurrent
68999-985-0568999098505500 CAPSULE in 1 BOTTLE (68999-985-05) 500 capsule2021-09-010000-00-00NoNoCurrent
68999-985-10689990985101000 CAPSULE in 1 BOTTLE (68999-985-10) 1000 capsule2021-09-010000-00-00NoNoCurrent
68999-985-506899909855050 CAPSULE in 1 BOTTLE (68999-985-50) 50 capsule2021-09-010000-00-00NoNoCurrent