doxycycline

Product NDC
71335-1479
Requested package NDC
71335-1479-2
11-digit product format
713351479
Labeler code
71335
Product ID
71335-1479_5f989cc1-48ae-41bb-b297-2f8c83760b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage71335-147971335-1479-2DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-147971335-1479-2DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A205115-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18
A205115-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18
A205115-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A205115-001AB
A205115-002AB
A205115-003AB

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 UTC2026-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2016-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2016-02-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205115-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205115-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205115-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205115-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205115-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205115-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205115-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205115-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205115-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205115-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205115-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205115-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205115-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205115-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205115-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205115-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205115-001AB18072bd15b7f6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEA-S Medication Solutions2c7795c9-9e4e-477a-ad9f-01e4c55c06b62026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEAvPAKa5b28a41-db12-af7c-e053-2995a90ace092026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.fef9580d-8850-4cbb-89eb-2b4d40ee59c92025-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEZydus Lifesciences Limitedaa01035d-8b4a-4fdc-bfdf-2b39df0d8fc92024-11-28Exact identifier
application applno (ANDA): 205115
application number: ANDA205115
doxycyclineDOXYCYCLINEBryant Ranch Prepack5f989cc1-48ae-41bb-b297-2f8c83760b6d2024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115
ndc (package): 71335-1479-2
ndc (product): 71335-1479
ndc11 (package): 71335147902
doxycyclineDOXYCYCLINEProficient Rx LPf3ba6c30-ada3-4a57-9ff8-30558202b9aa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205115
application number: ANDA205115

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649401Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f989cc1-48ae-41bb-b297-2f8c83760b6dAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1479-1doxycycline30 in 1 BOTTLECAPSULE30102
71335-1479-2doxycycline60 in 1 BOTTLECAPSULE60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1479DOXYCYCLINE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240725_5f989cc1-48ae-41bb-b297-2f8c83760b6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649401doxycycline monohydrate 50 MG Oral CapsulePSN5f989cc1-48ae-41bb-b297-2f8c83760b6d102
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD5f989cc1-48ae-41bb-b297-2f8c83760b6d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1479-27133514790260 CAPSULE in 1 BOTTLE (71335-1479-2) 60 capsule2020-01-160000-00-00NoNoCurrent