Doxycycline

Product NDC: 0713-0554
Requested package NDC: 0713-0554-01
11-digit product format: 007130554
Labeler code: 0713
Product ID: 0713-0554_d2c8d986-86bf-5528-e053-2a95a90acb28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: ANDA204446
Marketing category: ANDA
Marketing start: 2015-05-28
Marketing end: 2022-10-31
Substance: DOXYCYCLINE
Active strength: 75 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0713-0554	0713-0554-01	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204446-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28
A204446-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28
A204446-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204446-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204446-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204446-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204446-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204446-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204446-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204446-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204446-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204446-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204446-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204446-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204446-001	AB	1	`6a51e52b5d6a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0554-01	EA - Each	0713-0554	5d091b6f-46d8-4325-bb32-850615eae673	1	2018-09-05

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	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204446 application number: ANDA204446
Doxycycline	DOXYCYCLINE	Lupin Pharmaceuticals,Inc.	6512bf22-c211-4127-a8c8-2419656580f6	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204446 application number: ANDA204446

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0713-0554-01	00713055401	100 CAPSULE in 1 BOTTLE (0713-0554-01)	100 capsule	2017-11-26	2022-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline	Cosette Pharmaceuticals, Inc. \| PEL HEALTHCARE LLC	2021-12-10	HUMAN PRESCRIPTION DRUG LABEL	6
Mondoxyne NL	Sonoma Pharmaceuticals, Inc. \| PD-Rx Pharmaceuticals, Inc.	2019-10-23	HUMAN PRESCRIPTION DRUG LABEL	4