DOXYCYCLINE

Product NDC
61919-299
11-digit product format
619190299
Labeler code
61919
Product ID
61919-299_f10364fd-7b0a-457a-abc3-2fe77f49e6df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA065285
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-299IInactivated by FDA2026-08-03
excluded packagepackage61919-29961919-299-60IInactivated by FDA2026-08-03

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct61919-299IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-29961919-299-60IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct61919-299EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-29961919-299-60EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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

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
61919-299-602020-01-31C16284748780-19d75b9d0-4efd-f424-e053-dadaa90a57ceDOXYCYCLINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-299-60DOXYCYCLINE60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-299-60EA - Each61919-299eb55d236-d16c-40fc-9dc6-c789a3992db512017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-299DOXYCYCLINE TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20151027_d9ad1899-5f46-4bee-a9bf-2da253e20c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652673doxycycline monohydrate 50 MG Oral TabletPSNd9ad1899-5f46-4bee-a9bf-2da253e20c7c1
1652673doxycycline monohydrate 50 MG Oral TabletSCDd9ad1899-5f46-4bee-a9bf-2da253e20c7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-299-606191902996060 in 1 BOTTLEHistorical