Home DailyMed 371e62c6-bc13-4138-bde0-48ee2153f717 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:30:53 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N050805-001 ORACEA 40MG CAPSULE / ORAL AB RLD, RS 2006-05-26 c2088c7a36db…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 313 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N050805-001 7749532 2027-12-19 U-1063 Drug product c2088c7a36db…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…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.