Doxycycline

Product NDC
67296-1688
Requested package NDC
67296-1688-1
11-digit product format
672961688
Labeler code
67296
Product ID
67296-1688_d61f8515-4a39-ce54-e053-2995a90a6082
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065053
Marketing category
ANDA
Marketing start
2020-01-01
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
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 packagepackage67296-168867296-1688-1IInactivated 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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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
67296-1688-12024-01-30C16284748780-11030e365-2fc6-111a-e063-dadaa90a10e2Doxycycline mono 100mg
67296-1688-22024-01-30C16284748780-11030e365-2fc6-111a-e063-dadaa90a10e2Doxycycline mono 100mg
67296-1688-72024-01-30C16284748780-11030e365-2fc6-111a-e063-dadaa90a10e2Doxycycline mono 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1688-1Doxycycline2 in 1 BOTTLECAPSULE24
67296-1688-2Doxycycline20 in 1 BOTTLECAPSULE204
67296-1688-7Doxycycline14 in 1 BOTTLECAPSULE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1688DOXYCYCLINE CAPSULE [REDPHARM DRUG, INC.]4Legacy NDC, 3 package rows20220123_a37e73ab-0983-7a24-e053-2a95a90acdea.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 · 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNa37e73ab-0983-7a24-e053-2a95a90acdea4
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDa37e73ab-0983-7a24-e053-2a95a90acdea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1688-1672961688012 CAPSULE in 1 BOTTLE (67296-1688-1) 2 capsule2020-01-010000-00-00NoNoCurrent