Monodox

Product NDC: 16110-259
11-digit product format: 161100259
Labeler code: 16110
Product ID: 16110-259_a6d054f6-c27d-4641-ae0e-a6f59a196f54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Aqua Pharmaceuticals, LLC
Application: NDA050641
Marketing category: NDA
Marketing start: 1989-12-29
Marketing end: 0000-00-00
Substance: DOXYCYCLINE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	16110-259		I	Inactivated by FDA	2026-08-11
excluded package	package	16110-259	16110-259-04	I	Inactivated by FDA	2026-08-11
excluded package	package	16110-259	16110-259-07	I	Inactivated by FDA	2026-08-11

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 · 57 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	16110-259-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16110-259-04	`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	16110-259-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16110-259-04	`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	16110-259-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16110-259-04	`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	16110-259-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16110-259-04	`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	16110-259-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16110-259-04	`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	16110-259-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16110-259-04	`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	16110-259-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16110-259-04	`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	16110-259-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16110-259-04	`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	16110-259-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16110-259-04	`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	16110-259-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16110-259-04	`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	16110-259-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16110-259-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16110-259-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16110-259-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16110-259-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	16110-259-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16110-259-07	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	16110-259-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16110-259-07	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	16110-259-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16110-259-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16110-259-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16110-259-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16110-259-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16110-259-07	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16110-259-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16110-259-07	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16110-259-04	`8dfbde2a14a4…`	`c9ff85d89658…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050641-001	MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29
N050641-002	MONODOX	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10
N050641-003	MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18
N050641-004	MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N050641-001	AB
N050641-002	AB
N050641-003	AB
N050641-004	AB

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 4 · 154 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	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 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	N050641-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050641-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050641-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050641-004	AB	1	`d06236e962d9…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16110-259-04	2021-01-29	C162847	48780-1	ba0f9c33-4b23-a910-e053-dadaa90a0b85	MONODOX ® Doxycycline Monohydrate Capsules Aqua Pharmaceuticals, LLC Revised: March 2017 Rx only
16110-259-07	2021-01-29	C162847	48780-1	ba0f9c33-4b23-a910-e053-dadaa90a0b85	MONODOX ® Doxycycline Monohydrate Capsules Aqua Pharmaceuticals, LLC Revised: March 2017 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16110-259-04	Monodox	50 in 1 BOTTLE	CAPSULE	50		18
16110-259-07	Monodox	250 in 1 BOTTLE	CAPSULE	250		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16110-259-04	EA - Each	16110-259	2a5cf3d6-a597-4f14-8fac-b380b8a3c2e3	1	2012-07-24
16110-259-07	EA - Each	16110-259	c7a82a80-1f97-480d-a1ad-22d40e1dd3d4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16110-259	MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]	18	Legacy NDC, 2 package rows	20170503_a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2.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
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Chartwell RX, LLC.	02aa8731-d40f-43d8-8b63-a79a0503f8db	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641

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
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
1649401	doxycycline monohydrate 50 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
700408	doxycycline monohydrate 75 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205621	Monodox 100 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205619	Monodox 50 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
700410	Monodox 75 MG Oral Capsule	PSN	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205621	doxycycline monohydrate 100 MG Oral Capsule [Monodox]	SBD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205619	doxycycline monohydrate 50 MG Oral Capsule [Monodox]	SBD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
700410	doxycycline monohydrate 75 MG Oral Capsule [Monodox]	SBD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
1649401	doxycycline monohydrate 50 MG Oral Capsule	SCD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
700408	doxycycline monohydrate 75 MG Oral Capsule	SCD	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205621	Monodox (as doxycycline monohydrate) 100 MG Oral Capsule	SY	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205621	Monodox 100 MG Oral Capsule	SY	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
205619	Monodox 50 MG Oral Capsule	SY	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18
700410	Monodox 75 MG Oral Capsule	SY	a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
16110-259-04	16110025904	50 in 1 BOTTLE	Historical
16110-259-07	16110025907	250 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MONODOX ® Doxycycline Monohydrate Capsules Aqua Pharmaceuticals, LLC Revised: March 2017 Rx only	Aqua Pharmaceuticals, LLC	2017-04-26	HUMAN PRESCRIPTION DRUG LABEL	18