Doxycycline hyclate

Product NDC
68071-2777
Requested package NDC
68071-2777-4
11-digit product format
680712777
Labeler code
68071
Product ID
68071-2777_e2ad674e-e6db-dc38-e053-2a95a90a818d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
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#

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 packagepackage68071-277768071-2777-4IInactivated by FDA2026-08-11

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207774-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31
A207774-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207774-001AB
A207774-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207774-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207774-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207774-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207774-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207774-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207774-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207774-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207774-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207774-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207774-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207774-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207774-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207774-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207774-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207774-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207774-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207774-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207774-002AB1782e0a99824c…

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
68071-2777-42025-01-30C16284748780-12cef2736-6046-d83d-e063-dadaa90ab31fDOXYCYCLINE HYCLATE CAPSULES, USP
68071-2777-82025-01-30C16284748780-12cef2736-6046-d83d-e063-dadaa90ab31fDOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2777-4Doxycycline hyclate14 in 1 BOTTLECAPSULE142
68071-2777-8Doxycycline hyclate28 in 1 BOTTLECAPSULE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2777DOXYCYCLINE HYCLATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230427_e2ad6736-c532-1197-e053-2a95a90ae1f6.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline hyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsbea36ec9-f7fd-4295-bfbd-0228cffcddd72026-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATESportpharm LLC45c4b584-b7e2-4e91-a93d-aff14feb606f2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.df44c686-de34-487a-8741-a0a12993cab22026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEViona Pharmaceuticals Inc51d245a3-ef51-474a-bc91-377d5f42dde32025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepackb612d2f5-b703-47f0-b5eb-b66a7aeed5772025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEAsclemed USA, Inc.bed39bae-64c2-44b4-9c95-682ead4e67382025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP65b3a0e2-32a5-436a-b805-854fbffcb6112025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack30b041a0-8f5f-4d9f-b11b-106f7432955b2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEZydus Lifesciences Limitedfc8213e3-e546-495f-ac2c-3856db79c6e12024-08-16Exact identifier
application applno (ANDA): 207774
application number: ANDA207774

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNe2ad6736-c532-1197-e053-2a95a90ae1f62
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe2ad6736-c532-1197-e053-2a95a90ae1f62
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe2ad6736-c532-1197-e053-2a95a90ae1f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2777-46807127770414 CAPSULE in 1 BOTTLE (68071-2777-4) 14 capsule2022-06-300000-00-00NoNoCurrent