Doxycycline

Product NDC
61919-474
Requested package NDC
61919-474-20
11-digit product format
619190474
Labeler code
61919
Product ID
61919-474_9c93c4a2-a5a1-5060-e053-2a95a90afd72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA091605
Marketing category
ANDA
Marketing start
2015-01-01
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-47461919-474-20IInactivated by FDA2026-08-03

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 · 10 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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-47461919-474-20IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-47461919-474-20EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091605-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20
A091605-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20
A091605-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20
A091605-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091605-001AB
A091605-002AB
A091605-003AB
A091605-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091605-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091605-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091605-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091605-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091605-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091605-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091605-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091605-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091605-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091605-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091605-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091605-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091605-004AB1d06236e962d9…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEProficient Rx LP112c35d6-a397-45de-a57a-6e687cb27b4f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINENorthwind Health Company, LLCf2f1ee15-9323-1263-e053-2995a90a01fa2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2bcde264-5f6f-47f6-ae2e-1b7010deacf72025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEA-S Medication Solutions2b3b3c48-eb60-400c-bdfe-50635a136c902025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605

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
61919-474-202023-01-30C16284748780-1f386c64a-3911-0266-e053-dadaa90a7c1aDoxycycline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-474-20Doxycycline20 in 1 BOTTLETABLET203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-474-20EA - Each61919-47467449ef9-1ca2-49c7-93f8-5a17db5d6c3412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODIRECT RX (DOXYCYCLINE) TABLET [DIRECT RX]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DIRECT RX (DOXYCYCLINE) TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-474DOXYCYCLINE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200121_3f51c8ca-bf19-48b8-ac69-3830bff45087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN3f51c8ca-bf19-48b8-ac69-3830bff450873
1650142doxycycline monohydrate 100 MG Oral TabletSCD3f51c8ca-bf19-48b8-ac69-3830bff450873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-474-206191904742020 TABLET in 1 BOTTLE (61919-474-20) 20 tablet2015-01-010000-00-00NoNoCurrent