FDA.reportPublic FDA data

Doxycycline

Product NDC
64380-207
11-digit product format
643800207
Labeler code
64380
Product ID
64380-207_38deaa0a-0200-49e4-9251-a86dbe2119d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA065070
Marketing category
ANDA
Marketing start
2022-09-19
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
Rxcui1649429, 1650142, 1650444, 1652673

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-207-012024-04-24C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-207-022024-04-24C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-207-012024-01-30C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only
64380-207-022024-01-30C16284748780-11030e365-2864-111a-e063-dadaa90a10e2Doxycycline Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-207-01Doxycycline50 in 1 BOTTLETABLET506
64380-207-02Doxycycline250 in 1 BOTTLETABLET2506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-207-01EA - Each64380-207750398e8-8dd7-4523-a573-67812914099012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-207DOXYCYCLINE TABLET [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 2 package rows20250323_3b9888a2-ca16-43f7-ab6d-f03188ec2c0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650444doxycycline monohydrate 150 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1652673doxycycline monohydrate 50 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1649429doxycycline monohydrate 75 MG Oral TabletPSN3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650142doxycycline monohydrate 100 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1650444doxycycline monohydrate 150 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1652673doxycycline monohydrate 50 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6
1649429doxycycline monohydrate 75 MG Oral TabletSCD3b9888a2-ca16-43f7-ab6d-f03188ec2c0d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-207-016438002070150 TABLET in 1 BOTTLE (64380-207-01) 50 tablet2022-09-190000-00-00NoNoCurrent
64380-207-0264380020702250 TABLET in 1 BOTTLE (64380-207-02) 250 tablet2022-09-190000-00-00NoNoCurrent