Okebo

Product NDC
69482-475
Requested package NDC
69482-475-06
11-digit product format
694820475
Labeler code
69482
Product ID
69482-475_fa30cc44-939a-4bba-9db4-4aa4e100ee23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Encore Dermatology Inc.
Application
ANDA204234
Marketing category
ANDA
Marketing start
2017-11-20
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
75 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69482-47569482-475-06IInactivated by FDA2026-08-11

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 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A204234-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05
A204234-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05
A204234-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204234-001AB
A204234-002AB
A204234-003AB

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 UTC2026-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2014-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2014-03-058072bd15b7f6…

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 UTC2026-02A204234-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204234-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204234-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204234-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204234-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204234-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204234-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204234-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204234-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204234-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204234-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204234-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204234-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204234-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204234-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204234-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204234-001AB18072bd15b7f6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69482-475-06Okebo6 in 1 BOTTLECAPSULE64
69482-475-99Okebo100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69482-475-99EA - Each69482-4753673a6d3-a4e1-425e-8cd8-04c3102ab4d912017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69482-475OKEBO (DOXYCYCLINE) CAPSULE [ENCORE DERMATOLOGY INC.]4Legacy NDC, 2 package rows20200130_5e351090-afed-425b-e053-2a91aa0a206d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.fa2d9328-b688-47af-8c4d-dc328cf353922026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINENorthwind Health Company, LLCf3319f4f-b535-da12-e053-2995a90ac00f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINEProficient Rx LP00ea3641-18da-4a6f-a779-e16075464d2b2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.bcc65910-30d8-4807-ab61-607a563829242024-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204234
application number: ANDA204234

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
700408doxycycline monohydrate 75 MG Oral CapsulePSN5e351090-afed-425b-e053-2a91aa0a206d4
2045898Okebo 75 MG Oral CapsulePSN5e351090-afed-425b-e053-2a91aa0a206d4
2045898doxycycline monohydrate 75 MG Oral Capsule [Okebo]SBD5e351090-afed-425b-e053-2a91aa0a206d4
700408doxycycline monohydrate 75 MG Oral CapsuleSCD5e351090-afed-425b-e053-2a91aa0a206d4
2045898Okebo 75 MG Oral CapsuleSY5e351090-afed-425b-e053-2a91aa0a206d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69482-475-06694820475066 CAPSULE in 1 BOTTLE (69482-475-06) 6 capsule2017-11-200000-00-00NoNoCurrent