Doxycycline

Product NDC
0713-0572
11-digit product format
007130572
Labeler code
0713
Product ID
0713-0572_7603372c-888b-43c2-9753-aa38ce0b0ee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0713-0572DDiscontinued by firm2026-08-03
excluded packagepackage0713-05720713-0572-50DDiscontinued by firm2026-08-03
excluded packagepackage0713-05720713-0572-93DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 24 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0713-0572DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0713-05720713-0572-50DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0713-05720713-0572-93DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0572-50EA - Each0713-0572c72c8a2f-2110-4ee7-9a31-2554bd1db4e812021-08-05
0713-0572-93EA - Each0713-0572e2d4e791-59a6-4f2b-937d-75884860b1ce12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0572DOXYCYCLINE CAPSULE [COSETTE PHARMACEUTICALS, INC.]2Legacy NDC20241215_a990e1bd-e126-43eb-84dc-2537a5f0ff94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNc88a390f-bbc0-4e06-b6be-804f8e936fc6102
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDc88a390f-bbc0-4e06-b6be-804f8e936fc6102
1649990doxycycline monohydrate 100 MG Oral CapsulePSNf4238118-f827-19da-e053-2a95a90aa5f03
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDf4238118-f827-19da-e053-2a95a90aa5f03
1649990doxycycline monohydrate 100 MG Oral CapsulePSN1dfbe9e0-1563-4839-968e-7793af9aaf602
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD1dfbe9e0-1563-4839-968e-7793af9aaf602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0572-500071305725050 CAPSULE in 1 BOTTLE (0713-0572-50) 50 capsule2021-07-010000-00-00NoNoCurrent
0713-0572-9300713057293250 CAPSULE in 1 BOTTLE (0713-0572-93) 250 capsule2021-07-010000-00-00NoNoCurrent