Doxycycline Hyclate

Product NDC: 0463-6000
11-digit product format: 004636000
Labeler code: 0463
Product ID: 0463-6000_e5733d31-1d4a-46b5-9131-4ef99f7b6a84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET
Route: ORAL
Labeler: C.O. Truxton, Inc.
Application: ANDA062269
Marketing category: ANDA
Marketing start: 2013-11-25
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0463-6000		I	Inactivated by FDA		2026-08-07
excluded package	package	0463-6000	0463-6000-50	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0463-6000-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0463-6000-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0463-6000-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0463-6000-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0463-6000-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0463-6000-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0463-6000-50	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0463-6000-50	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0463-6000-50	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0463-6000-50	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0463-6000-50	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0463-6000-50	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0463-6000-50	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0463-6000-50	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0463-6000-50	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0463-6000-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0463-6000-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0463-6000-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0463-6000-50	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0463-6000-50	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0463-6000-50	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0463-6000-50	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062269-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08
A062269-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062269-002	AB
A062269-003	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 3 · 82 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	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1982-11-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL			1983-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A062269-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062269-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062269-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062269-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062269-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062269-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062269-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062269-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062269-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062269-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062269-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062269-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062269-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062269-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062269-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062269-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062269-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062269-002	AB	1	`87673890dc5c…`

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
0463-6000-50	2020-01-31	C162847	48780-1	9d75b9d0-1e6d-f424-e053-dadaa90a57ce	Doxycycline Hyclate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0463-6000-50	Doxycycline Hyclate	500 in 1 BOTTLE	TABLET	500		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0463-6000	DOXYCYCLINE HYCLATE TABLET [C.O. TRUXTON, INC.]	2	Legacy NDC, 1 package rows	20140210_33dd621e-d13f-4fa2-8da1-445fb42cccf9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug	44f2fdde-cf84-6f42-e063-6394a90af94e	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	ca63aa91-519d-429f-adfc-a4ec45367294	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
TARGADOX	DOXYCYCLINE HYCLATE	Journey Medical Corporation	83243f78-b984-46a4-a88a-c6a15c217b90	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	JG Pharma Inc.	10b8bf71-4311-41e8-a891-bab8bc86863f	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	860a1566-5857-ed88-e053-2991aa0ae2a4	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269

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
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	33dd621e-d13f-4fa2-8da1-445fb42cccf9	2
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	33dd621e-d13f-4fa2-8da1-445fb42cccf9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0463-6000-50	00463600050	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Tablets, USP	C.O. Truxton, Inc. \| Blu Caribe, Inc. \| Apotheca Inc.	2014-02-06	HUMAN PRESCRIPTION DRUG LABEL	2