Doxycycline Hyclate

Product NDC
71335-0635
11-digit product format
713350635
Labeler code
71335
Product ID
71335-0635_0d578667-4d46-486d-b709-63657a72493c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062031
Marketing category
ANDA
Marketing start
1990-01-01
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
2019-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0635DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-0DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-1DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-2DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-3DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-4DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-5DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-6DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-7DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-8DDiscontinued by firm2026-08-10
excluded packagepackage71335-063571335-0635-9DDiscontinued 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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0635-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0635-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0635-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0635-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0635-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0635-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0635-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0635-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0635-3cdf11ea48f46…ba0047e9e063…

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
A062031-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982
A062031-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062031-001AB
A062031-002AB

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 UTC2026-02A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062031-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A062031-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1982-10-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062031-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062031-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062031-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062031-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062031-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062031-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062031-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062031-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062031-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062031-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062031-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062031-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062031-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062031-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062031-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062031-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062031-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062031-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062031-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062031-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062031-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062031-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062031-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062031-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062031-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062031-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062031-002AB1782e0a99824c…