DOXYCYCLINE

Product NDC
68308-668
Requested package NDC
68308-668-30
11-digit product format
683080668
Labeler code
68308
Product ID
68308-668_4600dc6a-950d-4d84-aed9-da01fbd0db8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
NDA050805
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-02-27
Substance
DOXYCYCLINE
Active strength
40 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050805-001ORACEADOXYCYCLINE40MGCAPSULE / ORALABRLD, RS2006-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050805-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N050805-00177495322027-12-19U-1063Drug product

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-2684e616aacf4f…
2026-08-18 06:07:402026-07N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050805-001ORACEA40MGCAPSULE / ORALABRLD, RS2006-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-263f01610625f2…
2019-09-15 20:21 UTC2019-09N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050805-001ORACEA40MGCAPSULE / ORALRLD, RS2006-05-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N050805-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N050805-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050805-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050805-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050805-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050805-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050805-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050805-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050805-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050805-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050805-001AB18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050805-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N050805-00177495322027-12-19U-1063Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N050805-00177495322027-12-19U-1063Drug productcaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050805-00177495322027-12-19U-1063Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050805-00182067402025-12-24U-925Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050805-00177495322027-12-19U-1063Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N050805-00182067402025-12-24U-925Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050805-00177495322027-12-19U-1063Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050805-00182067402025-12-24U-925Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050805-00177495322027-12-19U-1063Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050805-00182067402025-12-24U-925Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050805-00177495322027-12-19U-1063Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00183944052024-04-07U-925Drug product2013-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00183944062024-04-07U-925Drug product2013-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00184703642024-04-07U-925Drug product2013-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00187094782024-04-07U-10632014-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00182067402025-12-24U-925Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050805-00177495322027-12-19U-1063Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00183944052024-04-07U-925Drug product2013-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00183944062024-04-07U-925Drug product2013-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00184703642024-04-07U-925Drug product2013-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00187094782024-04-07U-10632014-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00182067402025-12-24U-925Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050805-00177495322027-12-19U-1063Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00183944052024-04-07U-925Drug product2013-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00183944062024-04-07U-925Drug product2013-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00184703642024-04-07U-925Drug product2013-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00187094782024-04-07U-10632014-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00182067402025-12-24U-925Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050805-00177495322027-12-19U-1063Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00183944052024-04-07U-925Drug product2013-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00183944062024-04-07U-925Drug product2013-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00184703642024-04-07U-925Drug product2013-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00187094782024-04-07U-10632014-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00182067402025-12-24U-925Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050805-00177495322027-12-19U-1063Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050805-00183944052024-04-07U-925Drug product2013-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N050805-00183944062024-04-07U-925Drug product2013-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N050805-00184703642024-04-07U-925Drug product2013-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N050805-00187094782024-04-07U-10632014-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N050805-00182067402025-12-24U-925Drug productd06236e962d9…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
901399Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e6b3e17-aeee-4910-8e94-c7ac925b9ccaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68308-668-30DOXYCYCLINE30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-668-30EA - Each68308-6683c281e9b-9a33-4b11-85c8-bc65dd8bf97e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-668DOXYCYCLINE CAPSULE [MAYNE PHARMA INC.]3Current NDC, 1 package rows20230228_0e6b3e17-aeee-4910-8e94-c7ac925b9cca.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORACEADOXYCYCLINEGalderma Laboratories, L.P.aa15c93a-ff4c-447a-8a21-96da506d89972025-04-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 050805
application number: NDA050805
DOXYCYCLINEDOXYCYCLINEMayne Pharma Inc.0e6b3e17-aeee-4910-8e94-c7ac925b9cca2025-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 050805
application number: NDA050805
ndc (package): 68308-668-30
ndc (product): 68308-668
ndc11 (package): 68308066830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsulePSN0e6b3e17-aeee-4910-8e94-c7ac925b9cca4
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsuleSCD0e6b3e17-aeee-4910-8e94-c7ac925b9cca4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68308-668-306830806683030 CAPSULE in 1 BOTTLE (68308-668-30) 30 capsule2023-02-27NoNoCurrent