FDA.reportPublic FDA data

Doxycycline

Product NDC
60687-344
11-digit product format
606870344
Labeler code
60687
Product ID
60687-344_2abe1780-d1e3-a90a-e063-6294a90a64ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065285
Marketing category
ANDA
Marketing start
2017-12-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065285-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08
A065285-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08
A065285-003DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30
A065285-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A065285-001AB
A065285-002AB
A065285-003AB
A065285-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08a50c72e98297…
2026-08-01 22:54:322026-06A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08a50c72e98297…
2026-08-01 22:54:322026-06A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30a50c72e98297…
2026-08-01 22:54:322026-06A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065285-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065285-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065285-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A065285-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEAmerican Health Packagingadc6ba78-8dd7-47af-a7b4-c2215557696b2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065285
application number: ANDA065285
ndc (product): 60687-344
DoxycyclineDOXYCYCLINEBryant Ranch Prepack5f22094e-9297-4d1b-a37c-7846481b321e2024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065285
application number: ANDA065285
DoxycyclineDOXYCYCLINELannett Company, Inc.4999bbd9-44ed-4749-9730-be2337bdf4902024-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065285
application number: ANDA065285

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1650142Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
adc6ba78-8dd7-47af-a7b4-c2215557696bAvailable on FDA.report

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
60687-344-25Doxycycline30 in 1 BOX, UNIT-DOSETABLET, FILM COATED306
60687-344-95Doxycycline1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-344-25EA - Each60687-344b9922493-f78a-429a-8ff2-ea636fc2e35812018-01-12
60687-344-95EA - Each60687-34459d57281-6cb5-4083-99cb-e3066df02f5112018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-344DOXYCYCLINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20250104_adc6ba78-8dd7-47af-a7b4-c2215557696b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSNadc6ba78-8dd7-47af-a7b4-c2215557696b6
1650142doxycycline monohydrate 100 MG Oral TabletSCDadc6ba78-8dd7-47af-a7b4-c2215557696b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-344-256068703442530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-344-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-344-95) 30 blister pack2017-12-050000-00-00NoNoCurrent
60687-344-95606870344951 in 1 BLISTER PACKHistorical