Doxycycline

Product NDC
69263-501
Requested package NDC
69263-501-50
11-digit product format
692630501
Labeler code
69263
Product ID
69263-501_cd3d9284-8702-f2bb-e053-2995a90af632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Oaklock, LLC
Application
ANDA210664
Marketing category
ANDA
Marketing start
2020-03-19
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
2022-12-31
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 packagepackage69263-50169263-501-50DDiscontinued 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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210664-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210664-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-164b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORAL2020-03-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORAL2020-03-16c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210664-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2020-03-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210664-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210664-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210664-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210664-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210664-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210664-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210664-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210664-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210664-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210664-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210664-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210664-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210664-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210664-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210664-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210664-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210664-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210664-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210664-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210664-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210664-001AB15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210664-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210664-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210664-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210664-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210664-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210664-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210664-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210664-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210664-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210664-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210664-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210664-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210664-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210664-001AB1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210664
application number: ANDA210664
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.2c29f716-bdb0-437d-92a4-d856b87db9762026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210664
application number: ANDA210664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69263-501-506926305015050 TABLET, COATED in 1 BOTTLE (69263-501-50) 2020-03-190000-00-00NoNoCurrent