FDA.reportPublic FDA data

doxycycline

Product NDC
68382-707
11-digit product format
683820707
Labeler code
68382
Product ID
68382-707_9486a93f-bc2a-444a-a8d4-3bce410d21c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
Substance
DOXYCYCLINE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui700408, 1649401, 1649990

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
68382-707-01doxycycline100 in 1 BOTTLECAPSULE1009
68382-707-05doxycycline500 in 1 BOTTLECAPSULE5009
68382-707-06doxycycline30 in 1 BOTTLECAPSULE309
68382-707-10doxycycline1000 in 1 BOTTLECAPSULE10009
68382-707-16doxycycline90 in 1 BOTTLECAPSULE909
68382-707-18doxycycline50 in 1 BOTTLECAPSULE509
68382-707-21doxycycline250 in 1 BOTTLECAPSULE2509
68382-707-30doxycycline10 in 1 BLISTER PACKCAPSULE109
68382-707-77doxycycline10 in 1 CARTONCAPSULE109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-707-18EA - Each68382-70746b193e0-c3c4-4032-bddb-b416000e102712016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-707DOXYCYCLINE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 9 package rows20250507_fef9580d-8850-4cbb-89eb-2b4d40ee59c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN2c7795c9-9e4e-477a-ad9f-01e4c55c06b613
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD2c7795c9-9e4e-477a-ad9f-01e4c55c06b613
1649990doxycycline monohydrate 100 MG Oral CapsulePSNdedebcb4-3c3f-4487-a488-36af12640c9210
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDdedebcb4-3c3f-4487-a488-36af12640c9210
1649990doxycycline monohydrate 100 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649401doxycycline monohydrate 50 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
700408doxycycline monohydrate 75 MG Oral CapsulePSNfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649401doxycycline monohydrate 50 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99
700408doxycycline monohydrate 75 MG Oral CapsuleSCDfef9580d-8850-4cbb-89eb-2b4d40ee59c99
1649990doxycycline monohydrate 100 MG Oral CapsulePSN505b4f4f-ba7c-339d-e054-00144ff88e887
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD505b4f4f-ba7c-339d-e054-00144ff88e887
1649990doxycycline monohydrate 100 MG Oral CapsulePSNa5b28a41-db12-af7c-e053-2995a90ace095
1649990doxycycline monohydrate 100 MG Oral CapsulePSN7028b7f9-21cd-4c8e-97aa-a3e7d849939b5
1649990doxycycline monohydrate 100 MG Oral CapsulePSN31512ece-cb16-2a9a-e054-00144ff88e885
1649401doxycycline monohydrate 50 MG Oral CapsulePSNa5b28a41-db12-af7c-e053-2995a90ace095
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDa5b28a41-db12-af7c-e053-2995a90ace095
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD7028b7f9-21cd-4c8e-97aa-a3e7d849939b5
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD31512ece-cb16-2a9a-e054-00144ff88e885
1649401doxycycline monohydrate 50 MG Oral CapsuleSCDa5b28a41-db12-af7c-e053-2995a90ace095
1649990doxycycline monohydrate 100 MG Oral CapsulePSNf3ba6c30-ada3-4a57-9ff8-30558202b9aa3
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDf3ba6c30-ada3-4a57-9ff8-30558202b9aa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-707-0168382070701100 CAPSULE in 1 BOTTLE (68382-707-01) 100 capsule2016-03-140000-00-00NoNoCurrent
68382-707-0568382070705500 CAPSULE in 1 BOTTLE (68382-707-05) 500 capsule2016-03-140000-00-00NoNoCurrent
68382-707-066838207070630 CAPSULE in 1 BOTTLE (68382-707-06) 30 capsule2016-03-140000-00-00NoNoCurrent
68382-707-10683820707101000 CAPSULE in 1 BOTTLE (68382-707-10) 1000 capsule2016-03-140000-00-00NoNoCurrent
68382-707-166838207071690 CAPSULE in 1 BOTTLE (68382-707-16) 90 capsule2016-03-140000-00-00NoNoCurrent
68382-707-186838207071850 CAPSULE in 1 BOTTLE (68382-707-18) 50 capsule2016-03-140000-00-00NoNoCurrent
68382-707-2168382070721250 CAPSULE in 1 BOTTLE (68382-707-21) 250 capsule2016-03-140000-00-00NoNoCurrent
68382-707-306838207073010 in 1 BLISTER PACKHistorical
68382-707-776838207077710 BLISTER PACK in 1 CARTON (68382-707-77) / 10 CAPSULE in 1 BLISTER PACK (68382-707-30) 10 blister pack2016-03-140000-00-00NoNoCurrent