Doxycycline

Product NDC
70934-499
11-digit product format
709340499
Labeler code
70934
Product ID
70934-499_a8b0cc59-5d5f-a983-e053-2a95a90a5941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065053
Marketing category
ANDA
Marketing start
2020-02-19
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 productproduct70934-499DDiscontinued by firm2026-08-03
excluded packagepackage70934-49970934-499-20DDiscontinued 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 · 24 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 productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-49970934-499-20DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct70934-499DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-49970934-499-20DDiscontinued 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
A065053-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22
A065053-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22
A065053-003DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065053-001AB
A065053-002AB
A065053-003AB

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 UTC2026-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRS2000-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2003-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-11-228072bd15b7f6…

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 UTC2026-02A065053-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065053-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065053-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065053-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065053-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065053-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065053-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065053-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065053-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065053-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065053-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065053-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065053-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065053-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065053-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065053-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065053-001AB18072bd15b7f6…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries, Inc.829dbd3d-5c2b-47b8-96a5-423af78c93b92025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEDirect_Rxdfef600c-bceb-fbc9-e053-2a95a90ae6c02025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053
DoxycyclineDOXYCYCLINEBryant Ranch Prepack4b170180-21f4-4ee5-9e81-1607ab52cfca2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065053
application number: ANDA065053

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-499-20EA - Each70934-49970400e28-f950-43a9-a1da-b436af8cc9e912022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-499-207093404992020 CAPSULE in 1 BOTTLE, PLASTIC (70934-499-20) 20 capsule2020-02-190000-00-00NoNoCurrent