DOXYCYCLINE

Product NDC: 61919-433
11-digit product format: 619190433
Labeler code: 61919
Product ID: 61919-433_9c93bba4-8e44-74b3-e053-2995a90ad880
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: DirectRX
Application: ANDA065095
Marketing category: ANDA
Marketing start: 2015-12-17
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: 2021-12-31
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	61919-433		I	Inactivated by FDA		2026-08-10
excluded package	package	61919-433	61919-433-60	I	Inactivated by FDA		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 · 32 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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	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	61919-433-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
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	61919-433-60	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065095-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065095-001	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	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`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	A065095-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065095-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065095-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065095-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065095-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065095-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065095-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065095-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065095-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065095-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065095-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065095-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065095-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065095-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065095-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065095-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065095-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065095-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065095-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065095-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065095-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065095-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065095-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065095-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065095-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065095-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065095-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065095-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065095-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065095-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065095-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065095-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065095-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065095-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065095-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065095-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065095-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065095-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065095-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065095-001	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-433-60	2023-01-30	C162847	48780-1	f386c64a-40b2-0266-e053-dadaa90a7c1a	DOXYCYCLINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-433-60	DOXYCYCLINE	60 in 1 BOTTLE	TABLET, COATED	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-433	DOXYCYCLINE TABLET, COATED [DIRECTRX]	2	Legacy NDC, 1 package rows	20200130_272f6760-202a-0acf-e054-00144ff88e88.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	a34fbbc7-09dc-42d6-a075-f4ea8f170ba7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	10988250-b267-4f10-b264-5f127cc1ae18	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f7f6dc0d-cf8f-50b5-e053-6294a90a9e59	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	QPharma, Inc.	fbd0a22f-b365-c0a2-e053-6394a90a1e07	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	Golden State Medical Supply, Inc.	5fbef611-39db-4a8e-8f46-090c95a27042	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	e7c14a8e-c713-4f03-94e8-1ec9ae077d4d	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	53deb73a-c828-46e8-994e-d84e3bf8dc98	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	9b52e0a7-f024-4d8a-a59e-374946e60b44	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	272f6760-202a-0acf-e054-00144ff88e88	2
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	272f6760-202a-0acf-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-433-60	61919043360	60 TABLET, COATED in 1 BOTTLE (61919-433-60)	2015-12-17	0000-00-00	No	No	Current