doxycycline hyclate

Product NDC
46708-362
11-digit product format
467080362
Labeler code
46708
Product ID
46708-362_aec76b17-b6ca-41f3-b39b-65b7b3dd5972
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210527
Marketing category
ANDA
Marketing start
2018-06-18
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-362-50doxycycline hyclate50 in 1 BOTTLECAPSULE503
46708-362-71doxycycline hyclate500 in 1 BOTTLECAPSULE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-362DOXYCYCLINE HYCLATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20231212_e567b431-53fe-4e27-9b05-bf6eeb8abb51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNe567b431-53fe-4e27-9b05-bf6eeb8abb513
1649405doxycycline hyclate 50 MG Oral CapsulePSNe567b431-53fe-4e27-9b05-bf6eeb8abb513
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe567b431-53fe-4e27-9b05-bf6eeb8abb513
1649405doxycycline hyclate 50 MG Oral CapsuleSCDe567b431-53fe-4e27-9b05-bf6eeb8abb513
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe567b431-53fe-4e27-9b05-bf6eeb8abb513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-362-504670803625050 CAPSULE in 1 BOTTLE (46708-362-50) 50 capsule2018-06-180000-00-00NoNoCurrent
46708-362-7146708036271500 CAPSULE in 1 BOTTLE (46708-362-71) 500 capsule2018-06-180000-00-00NoNoCurrent