Doxycycline

Product NDC
55700-086
Requested package NDC
55700-086-28
11-digit product format
557000086
Labeler code
55700
Product ID
55700-086_cf73d903-cd80-4de4-9c14-871566e200c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA091605
Marketing category
ANDA
Marketing start
2012-01-05
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage55700-08655700-086-28DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-08655700-086-28DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A091605-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20
A091605-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20
A091605-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20
A091605-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091605-001AB
A091605-002AB
A091605-003AB
A091605-004AB

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 UTC2026-02A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20d06236e962d9…

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 UTC2026-02A091605-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091605-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091605-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-086-28EA - Each55700-086932f95c8-6e4c-46d6-b9a5-23e0af01e5a612015-04-03
55700-086-30EA - Each55700-08677f8f3b7-fdc7-4ddc-a35b-531a279c9eb512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEProficient Rx LP112c35d6-a397-45de-a57a-6e687cb27b4f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINENorthwind Health Company, LLCf2f1ee15-9323-1263-e053-2995a90a01fa2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2bcde264-5f6f-47f6-ae2e-1b7010deacf72025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEA-S Medication Solutions2b3b3c48-eb60-400c-bdfe-50635a136c902025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-086-285570000862828 TABLET in 1 BOTTLE (55700-086-28) 28 tablet2012-01-050000-00-00NoNoCurrent