Doxycycline Hyclate

Product NDC: 0527-1336
11-digit product format: 005271336
Labeler code: 0527
Product ID: 0527-1336_3f42e7f8-1c84-46ec-859e-edfd6761e6ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA065277
Marketing category: ANDA
Marketing start: 2005-11-10
Marketing end: 2022-07-31
Substance: DOXYCYCLINE HYCLATE
Active strength: 20 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0527-1336		D	Discontinued by firm	2026-08-10
excluded package	package	0527-1336	0527-1336-01	D	Discontinued by firm	2026-08-10
excluded package	package	0527-1336	0527-1336-06	D	Discontinued by firm	2026-08-10
excluded package	package	0527-1336	0527-1336-10	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 1 · 48 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	0527-1336-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1336-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1336-06	`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	0527-1336-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1336-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1336-06	`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	0527-1336-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1336-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1336-06	`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	0527-1336-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1336-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1336-06	`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	0527-1336-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1336-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1336-06	`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	0527-1336-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1336-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1336-06	`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	0527-1336-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1336-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1336-06	`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	0527-1336-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1336-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1336-06	`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	0527-1336-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1336-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1336-06	`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	0527-1336-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1336-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1336-06	`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	0527-1336-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1336-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1336-06	`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	0527-1336-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1336-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1336-06	`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
A065277-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065277-001	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.

Product history page 1 of 2 · 41 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	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065277-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2005-11-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065277-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065277-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065277-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065277-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065277-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065277-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065277-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065277-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065277-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065277-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065277-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065277-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065277-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065277-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065277-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065277-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065277-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065277-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065277-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065277-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065277-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065277-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065277-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065277-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065277-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065277-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065277-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065277-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065277-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065277-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065277-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065277-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065277-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065277-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065277-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065277-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065277-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065277-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065277-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065277-001	AB	1	`cb3db0bc1861…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1336-01	EA - Each	0527-1336	f5191f0c-9deb-4bd9-a914-f6aec9401678	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE TABLET, FILM COATED [LANNETT COMPANY, INC.]	8
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	b3294889-e8f8-42f1-9bd0-13d87572997a	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065277 application number: ANDA065277

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
283535	doxycycline hyclate 20 MG Oral Tablet	PSN	bdfcd442-de39-487d-bbab-510ce4fec8b3	1
283535	doxycycline hyclate 20 MG Oral Tablet	SCD	bdfcd442-de39-487d-bbab-510ce4fec8b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1336-01	00527133601	100 TABLET, FILM COATED in 1 BOTTLE (0527-1336-01)	2005-11-10	2022-07-31	No	No	Current
0527-1336-06	00527133606	60 TABLET, FILM COATED in 1 BOTTLE (0527-1336-06)	2005-11-10	2022-07-31	No	No	Current
0527-1336-10	00527133610	1000 TABLET, FILM COATED in 1 BOTTLE (0527-1336-10)	2005-11-10	2022-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Tablets, USP (Equivalent to 20 mg doxycycline)	Lannett Company, Inc.	2020-07-14	HUMAN PRESCRIPTION DRUG LABEL	21
Doxycycline Hyclate Tablets, USP (Equivalent to 20 mg doxycycline)	Aidarex Pharmaceuticals LLC	2012-09-19	HUMAN PRESCRIPTION DRUG LABEL	1