Doxycycline

Product NDC
50090-1787
Requested package NDC
50090-1787-0
11-digit product format
500901787
Labeler code
50090
Product ID
50090-1787_83779809-cfbd-4b69-90b4-4b36b2f4d79d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065285
Marketing category
ANDA
Marketing start
2005-12-08
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-178750090-1787-0IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065285-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065285-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065285-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065285-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065285-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065285-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065285-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065285-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065285-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065285-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065285-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065285-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065285-004AB1d06236e962d9…

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
50090-1787-02023-01-30C16284748780-1f386c64a-1e22-0266-e053-dadaa90a7c1aDoxycycline Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1787-0Doxycycline20 in 1 BOTTLETABLET, FILM COATED206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1787-0EA - Each50090-1787f5158f3b-dc67-40c4-9295-ce7f413b703e12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1787DOXYCYCLINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210226_9a267954-678a-4446-9c99-c68763b83b8f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN9a267954-678a-4446-9c99-c68763b83b8f6
1650142doxycycline monohydrate 100 MG Oral TabletSCD9a267954-678a-4446-9c99-c68763b83b8f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1787-05009017870020 TABLET, FILM COATED in 1 BOTTLE (50090-1787-0) 2015-04-200000-00-00NoNoCurrent