Doxycycline Hyclate

Product NDC: 68308-715
11-digit product format: 683080715
Labeler code: 68308
Product ID: 68308-715_48c52697-aa7f-47ea-81de-cab04f0323ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: NDA050795
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-07-08
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 150 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68308-715		D	Discontinued by firm	2026-08-07
excluded package	package	68308-715	68308-715-10	D	Discontinued by firm	2026-08-07
excluded package	package	68308-715	68308-715-30	D	Discontinued by firm	2026-08-07

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 · 34 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	68308-715-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68308-715-10	`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	68308-715-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68308-715-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68308-715-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68308-715-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68308-715-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68308-715-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68308-715-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68308-715-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68308-715-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68308-715-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68308-715-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68308-715-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68308-715-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68308-715-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68308-715-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68308-715-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68308-715-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68308-715-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68308-715-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68308-715-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68308-715-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050795-001	DORYX	DOXYCYCLINE HYCLATE	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2005-05-06
N050795-002	DORYX	DOXYCYCLINE HYCLATE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2005-05-06
N050795-003	DORYX	DOXYCYCLINE HYCLATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2008-06-20
N050795-004	DORYX	DOXYCYCLINE HYCLATE	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2013-04-11
N050795-005	DORYX	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2013-04-11
N050795-006	DORYX	DOXYCYCLINE HYCLATE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2014-12-19
N050795-007	DORYX MPC	DOXYCYCLINE HYCLATE	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2016-05-20
N050795-008	DORYX MPC	DOXYCYCLINE HYCLATE	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL	RLD	2016-05-20

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050795-001	8715724	2028-02-03		Drug product	2014-05-07
N050795-002	8715724	2028-02-03		Drug product	2014-05-07
N050795-003	8715724	2028-02-03		Drug product	2014-05-07
N050795-004	8715724	2028-02-03		Drug product	2014-05-07
N050795-005	8715724	2028-02-03		Drug product	2014-05-07
N050795-006	8715724	2028-02-03		Drug product	2015-02-10
N050795-007	8715724	2028-02-03		Drug product	2016-05-23
N050795-007	9295652	2034-10-23	U-918	Drug product	2016-05-23
N050795-007	9511031	2034-10-23		Drug product	2017-01-05
N050795-007	9446057	2034-12-23	U-918	Drug product	2016-09-09
N050795-008	8715724	2028-02-03		Drug product	2016-05-23
N050795-008	9295652	2034-10-23	U-918	Drug product	2016-05-23
N050795-008	9511031	2034-10-23		Drug product	2017-01-05
N050795-008	9446057	2034-12-23	U-918	Drug product	2016-09-09

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 9 · 328 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	N050795-001	DORYX	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-002	DORYX	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-003	DORYX	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2008-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-004	DORYX	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD	2013-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-005	DORYX	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2013-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-006	DORYX	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2014-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-007	DORYX MPC	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-008	DORYX MPC	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-001	DORYX	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-002	DORYX	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-003	DORYX	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2008-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-004	DORYX	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD	2013-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-005	DORYX	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2013-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-006	DORYX	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2014-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-007	DORYX MPC	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-008	DORYX MPC	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050795-001	DORYX	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-002	DORYX	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-003	DORYX	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2008-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-004	DORYX	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD	2013-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-005	DORYX	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2013-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-006	DORYX	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2014-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-007	DORYX MPC	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-008	DORYX MPC	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-001	DORYX	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-002	DORYX	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-003	DORYX	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2008-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-004	DORYX	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD	2013-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-005	DORYX	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2013-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-006	DORYX	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2014-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-007	DORYX MPC	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-008	DORYX MPC	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-001	DORYX	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-002	DORYX	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2005-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-003	DORYX	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2008-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-004	DORYX	EQ 80MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD	2013-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-005	DORYX	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2013-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-006	DORYX	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2014-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-007	DORYX MPC	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-008	DORYX MPC	EQ 120MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2016-05-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050795-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050795-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050795-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050795-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050795-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050795-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050795-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050795-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050795-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050795-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050795-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050795-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050795-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050795-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050795-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050795-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050795-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050795-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050795-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050795-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050795-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050795-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050795-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050795-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050795-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050795-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050795-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050795-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050795-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050795-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050795-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050795-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050795-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050795-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050795-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050795-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050795-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050795-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050795-001	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 718 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	N050795-001	8715724	2028-02-03		Drug product	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-002	8715724	2028-02-03		Drug product	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-003	8715724	2028-02-03		Drug product	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-004	8715724	2028-02-03		Drug product	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-005	8715724	2028-02-03		Drug product	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-006	8715724	2028-02-03		Drug product	2015-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-007	8715724	2028-02-03		Drug product	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-007	9295652	2034-10-23	U-918	Drug product	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-007	9511031	2034-10-23		Drug product	2017-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-007	9446057	2034-12-23	U-918	Drug product	2016-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-008	8715724	2028-02-03		Drug product	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-008	9295652	2034-10-23	U-918	Drug product	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-008	9511031	2034-10-23		Drug product	2017-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050795-008	9446057	2034-12-23	U-918	Drug product	2016-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-001	8715724	2028-02-03		Drug product	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-002	8715724	2028-02-03		Drug product	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-003	8715724	2028-02-03		Drug product	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-004	8715724	2028-02-03		Drug product	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-005	8715724	2028-02-03		Drug product	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-006	8715724	2028-02-03		Drug product	2015-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-007	8715724	2028-02-03		Drug product	2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-007	9295652	2034-10-23	U-918	Drug product	2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-007	9511031	2034-10-23		Drug product	2017-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-007	9446057	2034-12-23	U-918	Drug product	2016-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-008	8715724	2028-02-03		Drug product	2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-008	9295652	2034-10-23	U-918	Drug product	2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-008	9511031	2034-10-23		Drug product	2017-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050795-008	9446057	2034-12-23	U-918	Drug product	2016-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050795-001	8715724	2028-02-03		Drug product	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-002	8715724	2028-02-03		Drug product	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-003	8715724	2028-02-03		Drug product	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-004	8715724	2028-02-03		Drug product	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-005	8715724	2028-02-03		Drug product	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-006	8715724	2028-02-03		Drug product	2015-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-007	8715724	2028-02-03		Drug product	2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-007	9295652	2034-10-23	U-918	Drug product	2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-007	9511031	2034-10-23		Drug product	2017-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-007	9446057	2034-12-23	U-918	Drug product	2016-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-008	8715724	2028-02-03		Drug product	2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050795-008	9295652	2034-10-23	U-918	Drug product	2016-05-23	`6a471c1ec25d…`

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	Strength	SPL version
68308-715-10	Doxycycline Hyclate	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		15
68308-715-30	Doxycycline Hyclate	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-715-30	EA - Each	68308-715	2e161177-deb6-4c70-bc0a-07d7c0324265	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Doxycycline Hyclate	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Doxycycline Anhydrous	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Crospovidone	INACTIVE INGREDIENT	68401960MK	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MIDLOTHIAN LABORATORIES]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-715	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [MAYNE PHARMA COMMERCIAL LLC]	15	Legacy NDC, 2 package rows	20250417_cd2ab9b8-9619-4199-8a5d-83377b3274d1.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
DORYX MPC	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	f9277bb8-982d-444d-9325-35d5c53a2d35	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050795 application number: NDA050795
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Mayne Pharma Commercial LLC	cd2ab9b8-9619-4199-8a5d-83377b3274d1	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050795 application number: NDA050795 ndc (product): 68308-715

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
434018	doxycycline hyclate 100 MG Delayed Release Oral Tablet	PSN	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	PSN	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	PSN	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
406524	doxycycline hyclate 75 MG Delayed Release Oral Tablet	PSN	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
434018	doxycycline hyclate 100 MG Delayed Release Oral Tablet	SCD	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	SCD	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	SCD	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15
406524	doxycycline hyclate 75 MG Delayed Release Oral Tablet	SCD	cd2ab9b8-9619-4199-8a5d-83377b3274d1	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-715-10	68308071510	100 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-715-10)	2013-07-08	0000-00-00	No	No	Current
68308-715-30	68308071530	30 TABLET, DELAYED RELEASE in 1 BOTTLE (68308-715-30)	2017-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate	Mayne Pharma Commercial LLC \| Mayne Pharma International Pty Ltd \| Catalent Greenville, Inc.	2025-04-14	HUMAN PRESCRIPTION DRUG LABEL	15