Doxycycline

Product NDC
60760-215
Requested package NDC
60760-215-20
11-digit product format
607600215
Labeler code
60760
Product ID
60760-215_f06e8d19-c6ea-6cba-e053-2995a90a3adb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
St Marys Medical Park Pharmacy
Application
ANDA065095
Marketing category
ANDA
Marketing start
2003-07-02
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 packagepackage60760-21560760-215-20DDiscontinued by firm2026-08-10

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, 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…

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
A065095-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065095-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS2003-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065095-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2003-07-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065095-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065095-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065095-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065095-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065095-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065095-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065095-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065095-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065095-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065095-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065095-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065095-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065095-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065095-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065095-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065095-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065095-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065095-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065095-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065095-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065095-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065095-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065095-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065095-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065095-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065095-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065095-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065095-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065095-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065095-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065095-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065095-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065095-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065095-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065095-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065095-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065095-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065095-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065095-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065095-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-215-20EA - Each60760-2156ed904db-11f1-4789-953a-a2b56d81b37012015-10-02
60760-215-60EA - Each60760-2154b1cb969-3904-4fe3-b159-d0269627317d12017-06-15

DailyMed Socrata Ingredients#

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
DoxycyclineDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.c96d3986-9d92-4ec4-a319-a50aeb2f4fe72026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATECardinal Health 107, LLCa34fbbc7-09dc-42d6-a075-f4ea8f170ba72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaging10988250-b267-4f10-b264-5f127cc1ae182026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf7f6dc0d-cf8f-50b5-e053-6294a90a9e592026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEQPharma, Inc.fbd0a22f-b365-c0a2-e053-6394a90a1e072025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
DoxycyclineDOXYCYCLINE HYCLATEGolden State Medical Supply, Inc.5fbef611-39db-4a8e-8f46-090c95a270422025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalse7c14a8e-c713-4f03-94e8-1ec9ae077d4d2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
DoxycyclineDOXYCYCLINE HYCLATECardinal Health 107, LLC53deb73a-c828-46e8-994e-d84e3bf8dc982025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.9b52e0a7-f024-4d8a-a59e-374946e60b442025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions6772807d-a39e-47ce-9584-a08e7f8940d22025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065095
application number: ANDA065095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-215-206076002152020 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-215-20) 2010-12-010000-00-00NoNoCurrent