Doxycycline

Product NDC
59762-3690
11-digit product format
597623690
Labeler code
59762
Product ID
59762-3690_146dd5a7-c0c4-472e-a2d9-ee6184e31730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050007
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-05-01
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59762-3690DDiscontinued by firm2026-08-10
excluded packagepackage59762-369059762-3690-1DDiscontinued by firm2026-08-10
excluded packagepackage59762-369059762-3690-2DDiscontinued 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 1 · 36 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 packagepackage59762-3690-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59762-3690-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59762-3690-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59762-3690-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59762-3690-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59762-3690-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59762-3690-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59762-3690-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59762-3690-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59762-3690-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59762-3690-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59762-3690-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59762-3690-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59762-3690-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59762-3690-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59762-3690-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59762-3690-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59762-3690-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59762-3690-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59762-3690-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59762-3690-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59762-3690-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59762-3690-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59762-3690-2557ba5c1ecfa…9c80585c8c6e…

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
N050007-001VIBRAMYCINDOXYCYCLINE HYCLATEEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N050007-002VIBRAMYCINDOXYCYCLINE HYCLATEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982

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 UTC2026-02N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050007-001VIBRAMYCINEQ 50MG BASECAPSULE / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050007-001VIBRAMYCINEQ 50MG BASECAPSULE / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050007-001VIBRAMYCINEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050007-002VIBRAMYCINEQ 100MG BASECAPSULE / ORALABRLD, RS, Approved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050007-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050007-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050007-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050007-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050007-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050007-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050007-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050007-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050007-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050007-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050007-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050007-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050007-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050007-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050007-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050007-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050007-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050007-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050007-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050007-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050007-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050007-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050007-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050007-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050007-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050007-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050007-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050007-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050007-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050007-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050007-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050007-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050007-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050007-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050007-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050007-002AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3690-1EA - Each59762-369035b65dd3-d8ef-432e-ac96-af5d4fad5be912015-06-09
59762-3690-2EA - Each59762-36901b35a922-322e-4e98-a523-e476d728f40e12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE (DOXYCYCLINE HYCLATE) CAPSULE [GREENSTONE LLC]3