FDA.reportPublic FDA data

Doxycycline hyclate

Product NDC
70771-1358
11-digit product format
707711358
Labeler code
70771
Product ID
70771-1358_cb5b26e1-ae6e-46a2-9edd-e3e98ced7a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207774
Marketing category
ANDA
Marketing start
2018-09-12
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
70771-1358-0Doxycycline hyclate1000 in 1 BOTTLECAPSULE10006
70771-1358-1Doxycycline hyclate100 in 1 BOTTLECAPSULE1006
70771-1358-2Doxycycline hyclate10 in 1 BLISTER PACKCAPSULE106
70771-1358-4Doxycycline hyclate10 in 1 CARTONCAPSULE106
70771-1358-5Doxycycline hyclate500 in 1 BOTTLECAPSULE5006
70771-1358-7Doxycycline hyclate50 in 1 BOTTLECAPSULE506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1358DOXYCYCLINE HYCLATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 6 package rows20240821_fc8213e3-e546-495f-ac2c-3856db79c6e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNfc8213e3-e546-495f-ac2c-3856db79c6e16
1649405doxycycline hyclate 50 MG Oral CapsulePSNfc8213e3-e546-495f-ac2c-3856db79c6e16
1649988doxycycline hyclate 100 MG Oral CapsuleSCDfc8213e3-e546-495f-ac2c-3856db79c6e16
1649405doxycycline hyclate 50 MG Oral CapsuleSCDfc8213e3-e546-495f-ac2c-3856db79c6e16
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYfc8213e3-e546-495f-ac2c-3856db79c6e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1358-0707711358001000 CAPSULE in 1 BOTTLE (70771-1358-0) 1000 capsule2018-09-120000-00-00NoNoCurrent
70771-1358-170771135801100 CAPSULE in 1 BOTTLE (70771-1358-1) 100 capsule2018-09-120000-00-00NoNoCurrent
70771-1358-27077113580210 in 1 BLISTER PACKHistorical
70771-1358-47077113580410 BLISTER PACK in 1 CARTON (70771-1358-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1358-2) 10 blister pack2018-09-120000-00-00NoNoCurrent
70771-1358-570771135805500 CAPSULE in 1 BOTTLE (70771-1358-5) 500 capsule2018-09-120000-00-00NoNoCurrent
70771-1358-77077113580750 CAPSULE in 1 BOTTLE (70771-1358-7) 50 capsule2018-09-120000-00-00NoNoCurrent