Home NDC 68308-668-30 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050805-001 ORACEA DOXYCYCLINE 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050805-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050805-001 7749532 2027-12-19 U-1063 Drug 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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 312 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N050805-001 7749532 2027-12-19 U-1063 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050805-001 7749532 2027-12-19 U-1063 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050805-001 7749532 2027-12-19 U-1063 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050805-001 8206740 2025-12-24 U-925 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050805-001 7749532 2027-12-19 U-1063 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050805-001 8206740 2025-12-24 U-925 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050805-001 7749532 2027-12-19 U-1063 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050805-001 8206740 2025-12-24 U-925 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050805-001 7749532 2027-12-19 U-1063 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050805-001 8206740 2025-12-24 U-925 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050805-001 7749532 2027-12-19 U-1063 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 8206740 2025-12-24 U-925 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050805-001 7749532 2027-12-19 U-1063 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 8206740 2025-12-24 U-925 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050805-001 7749532 2027-12-19 U-1063 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 8206740 2025-12-24 U-925 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050805-001 7749532 2027-12-19 U-1063 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 8206740 2025-12-24 U-925 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050805-001 7749532 2027-12-19 U-1063 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050805-001 8394406 2024-04-07 U-925 Drug product 2013-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050805-001 8470364 2024-04-07 U-925 Drug product 2013-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050805-001 8709478 2024-04-07 U-1063 2014-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050805-001 8206740 2025-12-24 U-925 Drug product d06236e962d9…
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 Ingredient Strength DOXYCYCLINE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901399 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68308-668-30 DOXYCYCLINE 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-668 DOXYCYCLINE CAPSULE [MAYNE PHARMA INC.] 3 Current NDC, 1 package rows 20230228_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68308-668-30 68308066830 30 CAPSULE in 1 BOTTLE (68308-668-30) 30 capsule 2023-02-27 No No Current