Doxycycline

Product NDC
70934-325
11-digit product format
709340325
Labeler code
70934
Product ID
70934-325_b7b1907c-911f-8dcb-e053-2995a90a57eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA209582
Marketing category
ANDA
Marketing start
2019-03-25
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#

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-325IInactivated by FDA2026-09-14
excluded packagepackage70934-32570934-325-20IInactivated by FDA2026-09-14

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 · 30 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 packagepackage70934-325-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-325-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-325-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-325-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-325-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-325-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-325-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-325-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-325-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-325-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-325-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-325-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70934-325-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-325-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-325-201332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209582-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-28
A209582-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-28
A209582-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-28
A209582-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209582-001AB
A209582-002AB
A209582-003AB
A209582-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-2884e616aacf4f…
2026-09-14 22:38:342026-08A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2017-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-004DOXYCYCLINEEQ 150MG BASETABLET / ORALAB2017-09-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209582-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209582-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209582-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209582-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A209582-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209582-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209582-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209582-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209582-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209582-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209582-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209582-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209582-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209582-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209582-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209582-004AB15bbf6a4d5a75…

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
70934-325-202023-01-30C16284748780-1f386c649-a8a4-0266-e053-dadaa90a7c1aDoxycycline Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-325-20Doxycycline20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-325-20EA - Each70934-325f80fb8f5-d4bc-4b3f-944b-fed9cf040e3512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-325DOXYCYCLINE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20201231_8b9cd124-0d0a-24ee-e053-2a95a90ab838.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEA-S Medication Solutions55873d3e-09c4-4726-acfe-5da5815895752026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209582
application number: ANDA209582
DoxycyclineDOXYCYCLINEBryant Ranch Prepackb46208a2-5072-4df5-b2af-379f865545d22025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209582
application number: ANDA209582
DoxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.bc321932-b600-4659-a499-1853991b4ab92025-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209582
application number: ANDA209582
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf91373f2-c57b-f1f1-e053-6294a90a7bdd2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209582
application number: ANDA209582
DoxycyclineDOXYCYCLINEZydus Lifesciences Limitedc886b2e4-494a-4325-abaf-981fc3d01c662024-11-28Exact identifier
application applno (ANDA): 209582
application number: ANDA209582
DoxycyclineDOXYCYCLINEProficient Rx LPb83c4c4b-2885-43e7-b1c9-0b3bbf75528d2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209582
application number: ANDA209582

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN8b9cd124-0d0a-24ee-e053-2a95a90ab8382
1650142doxycycline monohydrate 100 MG Oral TabletSCD8b9cd124-0d0a-24ee-e053-2a95a90ab8382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-325-207093403252020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-325-20) 2019-03-250000-00-00NoNoCurrent