Doxycycline Hyclate

Product NDC
67296-1801
11-digit product format
672961801
Labeler code
67296
Product ID
67296-1801_d61f30c4-e4a1-78b7-e053-2995a90a54ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2016-10-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1801IInactivated by FDA2026-08-07
excluded packagepackage67296-180167296-1801-2IInactivated by FDA2026-08-07

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1801-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1801-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1801-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1801-21332a3947898…d4bfe170f9cd…

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
A062269-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08
A062269-003DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062269-002AB
A062269-003AB

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 UTC2026-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1982-11-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORAL1983-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062269-002AB187673890dc5c…

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
67296-1801-22024-07-25C16284748780-11030e365-5754-111a-e063-dadaa90a10e2Doxycycline Hyclate 100mg Tablets
67296-1801-22024-01-30C16284748780-11030e365-5754-111a-e063-dadaa90a10e2Doxycycline Hyclate 100mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1801-2Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1801DOXYCYCLINE HYCLATE TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20240727_b2e9cf0d-0b66-0e5d-e053-2a95a90a7874.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEHealth Department, Oklahoma Statef39365f9-eb64-00cb-e053-2995a90a8d802025-12-31WarningsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATERedpharm Drug44f2fdde-cf84-6f42-e063-6394a90af94e2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsca63aa91-519d-429f-adfc-a4ec453672942025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
TARGADOXDOXYCYCLINE HYCLATEJourney Medical Corporation83243f78-b984-46a4-a88a-c6a15c217b902025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEJG Pharma Inc.10b8bf71-4311-41e8-a891-bab8bc86863f2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions61195fc6-3fa7-4203-b526-477b483958562025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9cbd8699-e2c2-40d4-8797-e676f2a10eb22025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS65cac0b6-3550-48cf-bffa-cf42443c27312025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEEpic Pharma, LLC2b402587-8ecc-4fea-83ad-8071345b63562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.860a1566-5857-ed88-e053-2991aa0ae2a42024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNb2e9cf0d-0b66-0e5d-e053-2a95a90a78744
1650143doxycycline hyclate 100 MG Oral TabletSCDb2e9cf0d-0b66-0e5d-e053-2a95a90a78744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1801-26729618010220 TABLET, FILM COATED in 1 BOTTLE (67296-1801-2) 2016-10-010000-00-00NoNoCurrent