FDA.reportPublic FDA data

Doxycycline hyclate

Product NDC
76420-814
11-digit product format
764200814
Labeler code
76420
Product ID
76420-814_366a864f-98c6-7cf2-e063-6294a90a0268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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 HYCLATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405, 1649988

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
76420-814-00Doxycycline hyclate1000 in 1 BOTTLECAPSULE10004
76420-814-01Doxycycline hyclate100 in 1 BOTTLECAPSULE1004
76420-814-05Doxycycline hyclate500 in 1 BOTTLECAPSULE5004
76420-814-10Doxycycline hyclate10 in 1 BOTTLECAPSULE104
76420-814-14Doxycycline hyclate14 in 1 BOTTLECAPSULE144
76420-814-20Doxycycline hyclate20 in 1 BOTTLECAPSULE204
76420-814-30Doxycycline hyclate30 in 1 BOTTLECAPSULE304
76420-814-50Doxycycline hyclate50 in 1 BOTTLECAPSULE504
76420-814-60Doxycycline hyclate60 in 1 BOTTLECAPSULE604
76420-814-90Doxycycline hyclate90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-814DOXYCYCLINE HYCLATE CAPSULE [ASCLEMED USA, INC.]3Current NDC, 10 package rows20250321_bed39bae-64c2-44b4-9c95-682ead4e6738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649405doxycycline hyclate 50 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649405doxycycline hyclate 50 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYbed39bae-64c2-44b4-9c95-682ead4e67384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-814-00764200814001000 CAPSULE in 1 BOTTLE (76420-814-00) 1000 capsule2024-05-07NoNoHistorical
76420-814-0176420081401100 CAPSULE in 1 BOTTLE (76420-814-01) 100 capsule2024-05-07NoNoHistorical
76420-814-0576420081405500 CAPSULE in 1 BOTTLE (76420-814-05) 500 capsule2024-05-07NoNoHistorical
76420-814-107642008141010 CAPSULE in 1 BOTTLE (76420-814-10) 10 capsule2024-05-07NoNoHistorical
76420-814-147642008141414 CAPSULE in 1 BOTTLE (76420-814-14) 14 capsule2025-02-10NoNoHistorical
76420-814-207642008142020 CAPSULE in 1 BOTTLE (76420-814-20) 20 capsule2025-03-18NoNoHistorical
76420-814-307642008143030 CAPSULE in 1 BOTTLE (76420-814-30) 30 capsule2024-05-07NoNoHistorical
76420-814-507642008145050 CAPSULE in 1 BOTTLE (76420-814-50) 50 capsule2024-05-07NoNoHistorical
76420-814-607642008146060 CAPSULE in 1 BOTTLE (76420-814-60) 60 capsule2024-05-07NoNoHistorical
76420-814-907642008149090 CAPSULE in 1 BOTTLE (76420-814-90) 90 capsule2024-05-07NoNoHistorical