Doxycycline Hyclate

Product NDC: 68788-7474
Requested package NDC: 68788-7474-2
11-digit product format: 687887474
Labeler code: 68788
Product ID: 68788-7474_a2d349f7-c453-460b-aaf7-5c009b985985
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA062269
Marketing category: ANDA
Marketing start: 2020-02-28
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7474	68788-7474-2	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 · 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 · 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7474-1	EA - Each	68788-7474	e1d66d69-c19a-4ca2-a33e-500c5b4da223	1	2020-04-20
68788-7474-2	EA - Each	68788-7474	022aebfb-aaf5-40f0-9fc2-584b1336a170	1	2020-04-20
68788-7474-3	EA - Each	68788-7474	82eaf66b-44b2-4523-916c-46f943057d22	1	2020-04-20
68788-7474-6	EA - Each	68788-7474	f0c967a9-da59-4858-8ffb-483af2962adf	1	2020-04-20
68788-7474-8	EA - Each	68788-7474	d0d28e01-62b8-42ae-95ba-8739daa87dea	1	2020-04-20

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	2026-08-05	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7474-2	68788747402	20 TABLET, FILM COATED in 1 BOTTLE (68788-7474-2)	2020-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Tablets, USP 100 mg	Preferred Pharmaceuticals Inc.	2022-05-04	HUMAN PRESCRIPTION DRUG LABEL	3