Doxycycline Hyclate

Product NDC
71335-0861
Requested package NDC
71335-0861-8
11-digit product format
713350861
Labeler code
71335
Product ID
71335-0861_16d62b1d-92db-4cac-bda3-ecd5f808ce37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207289
Marketing category
ANDA
Marketing start
2016-06-28
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-086171335-0861-8IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-086171335-0861-8IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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
A207289-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207289-001AB

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 UTC2026-02A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-273f01610625f2…
2019-09-15 20:21 UTC2019-09A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27cb3db0bc1861…

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 UTC2026-02A207289-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207289-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207289-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207289-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207289-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207289-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207289-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207289-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207289-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207289-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207289-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207289-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207289-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207289-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207289-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207289-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207289-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207289-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207289-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207289-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207289-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207289-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207289-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207289-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207289-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207289-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207289-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207289-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207289-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207289-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207289-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207289-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207289-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207289-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207289-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207289-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207289-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207289-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207289-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207289-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
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
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9a9a558-4063-4aa7-9191-3875c97cf49aAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0861-0Doxycycline Hyclate6 in 1 BOTTLECAPSULE66
71335-0861-1Doxycycline Hyclate10 in 1 BOTTLECAPSULE106
71335-0861-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE206
71335-0861-3Doxycycline Hyclate30 in 1 BOTTLECAPSULE306
71335-0861-4Doxycycline Hyclate40 in 1 BOTTLECAPSULE406
71335-0861-5Doxycycline Hyclate60 in 1 BOTTLECAPSULE606
71335-0861-6Doxycycline Hyclate28 in 1 BOTTLECAPSULE286
71335-0861-7Doxycycline Hyclate14 in 1 BOTTLECAPSULE146
71335-0861-8Doxycycline Hyclate90 in 1 BOTTLECAPSULE906
71335-0861-9Doxycycline Hyclate365 in 1 BOTTLECAPSULE3656

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0861-2EA - Each71335-0861054c69c8-841c-4b36-8862-c52a4a9a2dde12018-10-11
71335-0861-3EA - Each71335-0861ab57cfc0-8cde-448c-9f6e-867d1dde8dbb12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0861DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20240517_f9a9a558-4063-4aa7-9191-3875c97cf49a.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 HyclateDOXYCYCLINEBryant Ranch Prepackf9a9a558-4063-4aa7-9191-3875c97cf49a2025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
ndc (package): 71335-0861-8
ndc (product): 71335-0861
ndc11 (package): 71335086108
Doxycycline HyclateDOXYCYCLINEAmneal Pharmaceuticals NY LLC49ecbf95-58e8-4f3c-b5d5-650a15d866cb2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINEAmneal Pharmaceuticals NY LLC79f3c026-7687-4a11-8d2e-03493531d3bf2025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINE HYCLATEAdvanced Rx Pharmacy of Tennessee, LLCb4f2ab4f-c32b-6435-e053-2995a90a69b62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINEProficient Rx LPe2151005-fb4a-485d-88ad-b44c4594d5792022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNf9a9a558-4063-4aa7-9191-3875c97cf49a6
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf9a9a558-4063-4aa7-9191-3875c97cf49a6
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf9a9a558-4063-4aa7-9191-3875c97cf49a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0861-87133508610890 CAPSULE in 1 BOTTLE (71335-0861-8) 90 capsule2018-07-110000-00-00NoNoCurrent