Doxycycline

Product NDC
67296-1025
Requested package NDC
67296-1025-4
11-digit product format
672961025
Labeler code
67296
Product ID
67296-1025_d60f9a37-90c1-7879-e053-2995a90a4d55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065055
Marketing category
ANDA
Marketing start
2000-12-01
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-102567296-1025-4IInactivated by FDA2026-08-03

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 · 15 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 packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-102567296-1025-4IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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 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 UTC2026-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18d06236e962d9…

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 UTC2026-02A065055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065055-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065055-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065055-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065055-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065055-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065055-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065055-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065055-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065055-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065055-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065055-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065055-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065055-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065055-001AB18072bd15b7f6…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1025-1Doxycycline14 in 1 BOTTLECAPSULE144
67296-1025-2Doxycycline20 in 1 BOTTLECAPSULE204
67296-1025-3Doxycycline28 in 1 BOTTLECAPSULE284
67296-1025-4Doxycycline2 in 1 BOTTLECAPSULE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1025DOXYCYCLINE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 4 package rows20220121_4e2c7065-03cb-158d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN4e2c7065-03cb-158d-e054-00144ff88e884
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD4e2c7065-03cb-158d-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1025-4672961025042 CAPSULE in 1 BOTTLE (67296-1025-4) 2 capsule2000-12-010000-00-00NoNoCurrent