Doxycycline

Product NDC
71335-2109
Requested package NDC
71335-2109-6
11-digit product format
713352109
Labeler code
71335
Product ID
71335-2109_f1057e47-64bd-440e-a2db-59d161081534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-210971335-2109-6DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 9 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-210971335-2109-6DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2109-67133521090610 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2109-6) 2022-06-060000-00-00NoNoCurrent