Doxycycline

Product NDC: 69263-501
11-digit product format: 692630501
Labeler code: 69263
Product ID: 69263-501_cd3d9284-8702-f2bb-e053-2995a90af632
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline hyclate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Oaklock, LLC
Application: ANDA210664
Marketing category: ANDA
Marketing start: 2020-03-19
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	69263-501		D	Discontinued by firm	2026-08-03
excluded package	package	69263-501	69263-501-05	D	Discontinued by firm	2026-08-03
excluded package	package	69263-501	69263-501-50	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 · 36 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	69263-501-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69263-501-50	`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	69263-501-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69263-501-50	`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	69263-501-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69263-501-50	`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	69263-501-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69263-501-50	`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	69263-501-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69263-501-50	`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	69263-501-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69263-501-50	`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	69263-501-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69263-501-50	`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	69263-501-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69263-501-50	`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	69263-501-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69263-501-50	`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	69263-501-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69263-501-50	`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	69263-501-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69263-501-50	`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	69263-501-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69263-501-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A210664-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2020-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210664-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL		2020-03-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210664-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210664-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210664-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210664-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210664-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210664-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210664-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210664-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210664-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210664-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210664-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210664-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210664-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210664-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210664-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210664-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210664-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210664-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210664-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210664-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210664-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210664-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210664-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210664-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210664-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210664-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210664-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210664-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210664-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210664-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210664-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210664-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210664-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210664-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210664-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210664-001	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69263-501-05	2023-07-23	DOXYCYCLINE HYCLATE TABLETS, USP Rx Only
69263-501-50	2023-07-23	DOXYCYCLINE HYCLATE TABLETS, USP Rx Only
69263-501-05	2023-01-30	DOXYCYCLINE HYCLATE TABLETS, USP Rx Only
69263-501-50	2023-01-30	DOXYCYCLINE HYCLATE TABLETS, USP Rx Only

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 HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210664 application number: ANDA210664
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2c29f716-bdb0-437d-92a4-d856b87db976	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210664 application number: ANDA210664

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69263-501-05	69263050105	500 TABLET, COATED in 1 BOTTLE (69263-501-05)	2020-03-19	0000-00-00	No	No	Current
69263-501-50	69263050150	50 TABLET, COATED in 1 BOTTLE (69263-501-50)	2020-03-19	0000-00-00	No	No	Current