Doxycycline Hyclate

Product NDC
67296-1431
11-digit product format
672961431
Labeler code
67296
Product ID
67296-1431_490df0fd-95eb-b265-e063-6294a90a8b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA207773
Marketing category
ANDA
Marketing start
2019-03-14
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage67296-1431-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1431-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1431-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1431-21332a3947898…d4bfe170f9cd…

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
A207773-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207773-001AB

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 UTC2026-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30cb3db0bc1861…

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 UTC2026-02A207773-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207773-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207773-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207773-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207773-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207773-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207773-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207773-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207773-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207773-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207773-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207773-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207773-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207773-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207773-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207773-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207773-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207773-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207773-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207773-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207773-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207773-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207773-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207773-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207773-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207773-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207773-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207773-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207773-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207773-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207773-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207773-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207773-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207773-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207773-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207773-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207773-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207773-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207773-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207773-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2027-12-31

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
bdacaaa7-b46e-ee0c-e053-2a95a90aea3cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1431-22024-08-07C16284748780-1f386c649-fe15-0266-e053-dadaa90a7c1aDoxycycline Hyclate 100mg Tab
67296-1431-22023-01-30C16284748780-1f386c649-fe15-0266-e053-dadaa90a7c1aDoxycycline Hyclate 100mg Tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1431-1Doxycycline Hyclate14 in 1 BOTTLETABLET143
67296-1431-2Doxycycline Hyclate20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1431DOXYCYCLINE HYCLATE TABLET [REDPHARM DRUG, INC.]2Current NDC, Legacy NDC, 2 package rows20240808_bdacaaa7-b46e-ee0c-e053-2a95a90aea3c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATERedPharm Drug, Inc.bdacaaa7-b46e-ee0c-e053-2a95a90aea3c2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
ndc (product): 67296-1431
Doxycycline HyclateDOXYCYCLINE HYCLATEViona Pharmaceuticals Inc763997f0-b35c-43cb-a792-3e0bae5895362025-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack5b4390ed-a0ec-4ef8-864c-8a33a83653f92025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline HyclateDOXYCYCLINE HYCLATENCS HealthCare of KY, LLC dba Vangard Labs104cac0f-7c99-4faf-ba08-0159ed767a3e2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline hyclateDOXYCYCLINE HYCLATEZydus Lifesciences Limited68b3aba5-f1e4-4cdf-b244-0302aa8595fe2024-08-16Exact identifier
application applno (ANDA): 207773
application number: ANDA207773

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3
1650143doxycycline hyclate 100 MG Oral TabletSCDbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1431-16729614310114 TABLET in 1 BOTTLE (67296-1431-1) 14 tablet2021-03-01NoNoCurrent
67296-1431-26729614310220 TABLET in 1 BOTTLE (67296-1431-2) 20 tablet2021-03-010000-00-00NoNoCurrent