ORACEA

Product NDC: 0299-3822
11-digit product format: 002993822
Labeler code: 0299
Product ID: 0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE
Dosage form: CAPSULE
Route: ORAL
Labeler: Galderma Laboratories, L.P.
Application: NDA050805
Marketing category: NDA
Marketing start: 2010-05-14
Substance: DOXYCYCLINE
Active strength: 40 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0299-3822	0299-3822-02	D	Discontinued by firm	2026-09-14
excluded package	package	0299-3822	0299-3822-04	D	Discontinued by firm	2026-09-14
excluded package	package	0299-3822	0299-3822-05	D	Discontinued by firm	2026-09-14
excluded package	package	0299-3822	0299-3822-06	D	Discontinued by firm	2026-09-14
excluded package	package	0299-3822	0299-3822-07	D	Discontinued by firm	2026-09-14

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0299-3822-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0299-3822-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0299-3822-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0299-3822-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0299-3822-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0299-3822-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0299-3822-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0299-3822-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0299-3822-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0299-3822-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0299-3822-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0299-3822-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0299-3822-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0299-3822-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0299-3822-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0299-3822-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0299-3822-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0299-3822-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0299-3822-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0299-3822-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0299-3822-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0299-3822-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0299-3822-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0299-3822-06	`cdf11ea48f46…`	`ba0047e9e063…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050805-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050805-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050805-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050805-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050805-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050805-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050805-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050805-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050805-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050805-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050805-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050805-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050805-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050805-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050805-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050805-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050805-001	AB	1	`a50c72e98297…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ORACEA
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901399	Internal RxNorm lookup
901401	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa15c93a-ff4c-447a-8a21-96da506d8997	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0299-3822-02	ORACEA	12 in 1 BOX	CAPSULE	12	23
0299-3822-02	ORACEA	8 in 1 TRAY	CAPSULE	8	23
0299-3822-04	ORACEA	4 in 1 BLISTER PACK	CAPSULE	4	23
0299-3822-05	ORACEA	4 in 1 BLISTER PACK	CAPSULE	4	23
0299-3822-05	ORACEA	8 in 1 PACKAGE	CAPSULE	8	23
0299-3822-06	ORACEA	16 in 1 BOX	CAPSULE	16	23
0299-3822-06	ORACEA	1 in 1 KIT	CAPSULE	1	23
0299-3822-07	ORACEA	4 in 1 TRAY	CAPSULE	4	23
0299-3822-07	ORACEA	24 in 1 BOX	CAPSULE	24	23
0299-3822-30	ORACEA	30 in 1 BOTTLE	CAPSULE	30	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0299-3822-30	EA - Each	0299-3822	371e62c6-bc13-4138-bde0-48ee2153f717	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ORACEA (DOXYCYCLINE) CAPSULE, DELAYED RELEASE [GALDERMA LABORATORIES, L.P.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0299-3822	ORACEA (DOXYCYCLINE) CAPSULE [GALDERMA LABORATORIES, L.P.]	19	Current NDC, Legacy NDC, 10 package rows	20250417_aa15c93a-ff4c-447a-8a21-96da506d8997.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORACEA	DOXYCYCLINE	Galderma Laboratories, L.P.	aa15c93a-ff4c-447a-8a21-96da506d8997	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050805 application number: NDA050805 ndc (product): 0299-3822
DOXYCYCLINE	DOXYCYCLINE	Mayne Pharma Inc.	0e6b3e17-aeee-4910-8e94-c7ac925b9cca	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050805 application number: NDA050805

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
901399	doxycycline anhydrous 40 MG Delayed Release Oral Capsule	PSN	aa15c93a-ff4c-447a-8a21-96da506d8997	23
901401	Oracea 40 MG Delayed Release Oral Capsule	PSN	aa15c93a-ff4c-447a-8a21-96da506d8997	23
901401	doxycycline anhydrous 40 MG Delayed Release Oral Capsule [Oracea]	SBD	aa15c93a-ff4c-447a-8a21-96da506d8997	23
901399	doxycycline anhydrous 40 MG Delayed Release Oral Capsule	SCD	aa15c93a-ff4c-447a-8a21-96da506d8997	23
901401	Oracea 40 MG Delayed Release Oral Capsule	SY	aa15c93a-ff4c-447a-8a21-96da506d8997	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0299-3822-02	00299382202	12 TRAY in 1 BOX (0299-3822-02) > 8 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK	12 tray	2015-02-01	0000-00-00	No	No	Current
0299-3822-04	00299382204	4 CAPSULE in 1 BLISTER PACK (0299-3822-04)	4 capsule	2010-05-14	0000-00-00	No	No	Current
0299-3822-05	00299382205	8 BLISTER PACK in 1 PACKAGE (0299-3822-05) > 4 CAPSULE in 1 BLISTER PACK	8 blister pack	2010-05-14	0000-00-00	No	No	Current
0299-3822-06	00299382206	16 KIT in 1 BOX (0299-3822-06) > 1 BLISTER PACK in 1 KIT > 4 CAPSULE in 1 BLISTER PACK	16 kit	2010-05-14	0000-00-00	No	No	Current
0299-3822-07	00299382207	24 TRAY in 1 BOX (0299-3822-07) > 4 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK	24 tray	2015-02-01	0000-00-00	No	No	Current
0299-3822-30	00299382230	30 CAPSULE in 1 BOTTLE (0299-3822-30)	30 capsule	2010-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORACEA	Galderma Laboratories, L.P. \| Catalent Pharma Solutions, LLC	2025-04-16	HUMAN PRESCRIPTION DRUG LABEL	23