Doxycycline Hyclate

Product NDC
0463-2013
11-digit product format
004632013
Labeler code
0463
Product ID
0463-2013_7267994f-589b-407f-ba8b-7971a0d07a58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
C.O. Truxton, Inc.
Application
ANDA065103
Marketing category
ANDA
Marketing start
2013-01-14
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0463-2013IInactivated by FDA2026-08-17
excluded packagepackage0463-20130463-2013-05IInactivated by FDA2026-08-17
excluded packagepackage0463-20130463-2013-50IInactivated by FDA2026-08-17

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 2 · 63 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 packagepackage0463-2013-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0463-2013-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0463-2013-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0463-2013-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0463-2013-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0463-2013-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0463-2013-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0463-2013-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0463-2013-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0463-2013-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0463-2013-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0463-2013-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0463-2013-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0463-2013-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0463-2013-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0463-2013-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0463-2013-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0463-2013-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0463-2013-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0463-2013-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0463-2013-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0463-2013-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0463-2013-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0463-2013-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0463-2013-058af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0463-2013-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0463-2013-05834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0463-2013-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0463-2013-051332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0463-2013-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0463-2013-05fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0463-2013-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0463-2013-0586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0463-2013-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0463-2013-05bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0463-2013-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0463-2013-058dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0463-2013-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0463-2013-05e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0463-2013-50e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065103-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065103-001DOXYCYCLINE HYCLATEEQ 20MG BASECAPSULE / ORAL2005-05-13e64feba35796…

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
0463-2013-052020-01-31C16284748780-19d75b9cf-e6c6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP
0463-2013-502020-01-31C16284748780-19d75b9cf-e6c6-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0463-2013-05Doxycycline Hyclate50 in 1 BOTTLECAPSULE501
0463-2013-50Doxycycline Hyclate500 in 1 BOTTLECAPSULE5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0463-2013DOXYCYCLINE HYCLATE CAPSULE [C.O. TRUXTON, INC.]1Legacy NDC, 2 package rows20130613_8d8ea1c1-0c89-4a10-85bb-de2c96ca34f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8d8ea1c1-0c89-4a10-85bb-de2c96ca34f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0463-2013-050046320130550 in 1 BOTTLEHistorical
0463-2013-5000463201350500 in 1 BOTTLEHistorical