Doxycycline

Product NDC
42783-601
11-digit product format
427830601
Labeler code
42783
Product ID
42783-601_881b762a-b1e5-436c-800a-0f058967d0a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Elorac, Inc.
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
E
Listing certified through
2018-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42783-601DDiscontinued by firm2026-08-17
excluded productproduct42783-601IInactivated by FDA2026-08-17
excluded productproduct42783-601IInactivated by FDA2026-08-17
excluded packagepackage42783-60142783-601-30DDiscontinued by firm2026-08-17
excluded packagepackage42783-60142783-601-60DDiscontinued by firm2026-08-17
excluded packagepackage42783-60142783-601-30IInactivated by FDA2026-08-17
excluded packagepackage42783-60142783-601-60IInactivated by FDA2026-08-17

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 3 · 124 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42783-601-60DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42783-601-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42783-601-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42783-601-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42783-601-60DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42783-601-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42783-601-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42783-601-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42783-601-60DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42783-601-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42783-601-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42783-601-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42783-601-60DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42783-601-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42783-601-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42783-601-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42783-601-60DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42783-601-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42783-601-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42783-601-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42783-601-60DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42783-601-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42783-601-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42783-601-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42783-601-60DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42783-601-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42783-601-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42783-601-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42783-601-60DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42783-601-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42783-601-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42783-601-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42783-601-60DDiscontinued by firm0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065285-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-002DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-003DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2008-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2008-07-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065285-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065285-004AB1caaa826d4ba7…
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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42783-601-302020-01-31C16284748780-19d75b9d0-4ed0-f424-e053-dadaa90a57ceDoxycycline Tablets, USP
42783-601-602020-01-31C16284748780-19d75b9d0-4e9a-f424-e053-dadaa90a57ceDoxycycline Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-601-60Doxycycline60 in 1 BOTTLETABLET, FILM COATED6011
42783-601-30Doxycycline30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
DOXYCYCLINEACTIVE INGREDIENTN12000U13OBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4THBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
DOXYCYCLINEACTIVE INGREDIENTN12000U13OBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4THBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
LAURETH-7INACTIVE INGREDIENTZ95S6G8201BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-601DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11Legacy NDC, 1 package rows20151015_3e526226-0ac6-4357-af89-23639e23ef58.zip
42783-601DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7Legacy NDC, 1 package rows20151015_d9229004-5d44-4d36-a3ba-4d8826b143f1.zip
42783-601BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4Legacy NDC20151030_ddd9a47e-7d7c-4d0c-aaa6-32702570f696.zip
42783-601BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2Legacy NDC20151017_92ab3004-f719-4861-ba6a-c93ec9ab94f4.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 TabletPSN3e526226-0ac6-4357-af89-23639e23ef5811
1650142doxycycline monohydrate 100 MG Oral TabletSCD3e526226-0ac6-4357-af89-23639e23ef5811
1650142doxycycline monohydrate 100 MG Oral TabletPSNd9229004-5d44-4d36-a3ba-4d8826b143f17
1650142doxycycline monohydrate 100 MG Oral TabletSCDd9229004-5d44-4d36-a3ba-4d8826b143f17
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapPSNddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1650142doxycycline monohydrate 100 MG Oral TabletPSNddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 44 MG/ML Medicated Liquid SoapSCDddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1650142doxycycline monohydrate 100 MG Oral TabletSCDddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapSYddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapPSN92ab3004-f719-4861-ba6a-c93ec9ab94f42
1650142doxycycline monohydrate 100 MG Oral TabletPSN92ab3004-f719-4861-ba6a-c93ec9ab94f42
1543390benzoyl peroxide 44 MG/ML Medicated Liquid SoapSCD92ab3004-f719-4861-ba6a-c93ec9ab94f42
1650142doxycycline monohydrate 100 MG Oral TabletSCD92ab3004-f719-4861-ba6a-c93ec9ab94f42
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapSY92ab3004-f719-4861-ba6a-c93ec9ab94f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42783-601-304278306013030 in 1 BOTTLEHistorical
42783-601-604278306016060 in 1 BOTTLEHistorical