Home NDC 66993-815 DOXYCYCLINE
Product NDC 66993-815
11-digit product format 669930815
Labeler code 66993
Product ID 66993-815_f5edfbdc-7314-4a03-bd5a-c836e7a7e337
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form CAPSULE
Route ORAL
Labeler Prasco Laboratories
Application NDA050805
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-04-01
Marketing end 0000-00-00
Substance DOXYCYCLINE
Active strength 40 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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66993-815-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66993-815-30 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050805-001 ORACEA 40MG CAPSULE / ORAL RLD, RS 2006-05-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 310 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-10-29 15:01 UTC 2024-10 N050805-001 7749532 2027-12-19 U-1063 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050805-001 8394405 2024-04-07 U-925 Drug product 2013-03-25 79d66fd596c7…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM DOXYCYCLINE CAPSULE, DELAYED RELEASE [PRASCO LABORATORIES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-815 DOXYCYCLINE CAPSULE [PRASCO LABORATORIES] 7 Legacy NDC 20240203_22b7035c-6874-4cf4-ad73-06a105bffc64.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66993-815-30 66993081530 30 CAPSULE in 1 BOTTLE (66993-815-30) 30 capsule 2015-04-01 0000-00-00 No No Current