Doxycycline

Product NDC
40032-791
Requested package NDC
40032-791-11
11-digit product format
400320791
Labeler code
40032
Product ID
40032-791_69d6f881-5c24-44c9-ae77-de969367ede4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
75 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage40032-79140032-791-11IInactivated by FDA2026-08-03

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204446-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28
A204446-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28
A204446-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204446-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204446-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204446-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204446-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204446-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204446-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204446-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204446-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204446-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204446-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204446-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204446-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204446-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204446-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204446-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204446-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204446-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204446-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204446-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A204446-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A204446-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204446-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A204446-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A204446-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204446-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A204446-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A204446-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204446-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A204446-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A204446-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204446-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A204446-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A204446-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204446-001AB16a51e52b5d6a…

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
40032-791-01Doxycycline100 in 1 BOTTLECAPSULE1005
40032-791-10Doxycycline1000 in 1 BOTTLECAPSULE10005
40032-791-11Doxycycline50 in 1 BOTTLECAPSULE505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-791DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]5Legacy NDC, 3 package rows20191221_3d07e4d0-fe80-4eb1-8369-0a995a638713.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446
DoxycyclineDOXYCYCLINELupin Pharmaceuticals,Inc.6512bf22-c211-4127-a8c8-2419656580f62024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649401doxycycline monohydrate 50 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
700408doxycycline monohydrate 75 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135
700408doxycycline monohydrate 75 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-791-114003207911150 CAPSULE in 1 BOTTLE (40032-791-11) 50 capsule2015-05-280000-00-00NoNoCurrent