Doxycycline

Product NDC
55154-7128
11-digit product format
551547128
Labeler code
55154
Product ID
55154-7128_2d82899d-621b-47cc-9b99-7a10c8815eac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA065095
Marketing category
ANDA
Marketing start
2013-03-22
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1650143Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53deb73a-c828-46e8-994e-d84e3bf8dc98Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7128-5Doxycycline1 in 1 BLISTER PACKTABLET, COATED114
55154-7128-5Doxycycline10 in 1 BAGTABLET, COATED1014

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7128DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20240314_53deb73a-c828-46e8-994e-d84e3bf8dc98.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 · 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
ndc (product): 55154-7128
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN53deb73a-c828-46e8-994e-d84e3bf8dc9814
1650143doxycycline hyclate 100 MG Oral TabletSCD53deb73a-c828-46e8-994e-d84e3bf8dc9814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7128-05515471280010 BLISTER PACK in 1 BAG (55154-7128-0) > 1 TABLET, COATED in 1 BLISTER PACK10 blister pack2013-03-220000-00-00NoNoCurrent
55154-7128-55515471280510 BLISTER PACK in 1 BAG (55154-7128-5) / 1 TABLET, COATED in 1 BLISTER PACK10 blister pack2013-03-22NoNoCurrent