Doxycycline Monohydrate

Product NDC: 43063-529
11-digit product format: 430630529
Labeler code: 43063
Product ID: 43063-529_81b9e40a-cef2-4e2f-e053-2a91aa0a057a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA050641
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2005-02-07
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-529		D	Discontinued by firm	2026-08-10
excluded package	package	43063-529	43063-529-02	D	Discontinued by firm	2026-08-10
excluded package	package	43063-529	43063-529-06	D	Discontinued by firm	2026-08-10
excluded package	package	43063-529	43063-529-14	D	Discontinued by firm	2026-08-10
excluded package	package	43063-529	43063-529-20	D	Discontinued by firm	2026-08-10
excluded package	package	43063-529	43063-529-28	D	Discontinued by firm	2026-08-10

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 2 · 72 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	43063-529-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-529-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-529-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-529-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-529-28	`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	43063-529-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-529-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-529-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-529-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-529-28	`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	43063-529-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-529-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-529-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-529-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-529-28	`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	43063-529-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-529-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-529-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-529-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-529-28	`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	43063-529-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-529-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-529-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-529-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-529-28	`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	43063-529-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-529-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-529-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-529-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-529-28	`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	43063-529-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-529-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-529-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-529-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-529-28	`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	43063-529-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-529-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-529-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-529-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-529-28	`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	43063-529-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-529-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-529-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-529-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-529-28	`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	43063-529-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-529-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-529-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-529-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-529-28	`ad56d346431e…`	`cc804d4bbf1e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-529-02	EA - Each	43063-529	f7ba28dd-07ec-4efe-baac-32109bc0578d	1	2017-08-11
43063-529-06	EA - Each	43063-529	f1ffa261-acbc-472f-a76b-cd8007146c19	1	2014-08-01
43063-529-14	EA - Each	43063-529	b52003af-97d6-4666-81a2-0f75e9d17389	1	2014-09-03
43063-529-20	EA - Each	43063-529	0f627940-133e-4c7b-b4f6-e4544d5cc75d	1	2015-06-09
43063-529-28	EA - Each	43063-529	3b2b13bb-5e21-4a3a-a62b-e25089a34573	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Monohydrate Capsules Revised: May 2017 Rx only 236306	PD-Rx Pharmaceuticals, Inc.	2019-02-12	HUMAN PRESCRIPTION DRUG LABEL	24