doxycycline hyclate

Product NDC: 68382-709
Requested package NDC: 68382-709-05
11-digit product format: 683820709
Labeler code: 68382
Product ID: 68382-709_38662a6c-8d26-43d6-a6af-722b15d4a41a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline hyclate
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206772
Marketing category: ANDA
Marketing start: 2018-12-21
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	68382-709	68382-709-05	D	Discontinued by firm		2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-709	68382-709-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-709	68382-709-05	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206772-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21
A206772-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21
A206772-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206772-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206772-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206772-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-12-21	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-709-05	68382070905	500 TABLET in 1 BOTTLE (68382-709-05)	500 tablet	2018-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxycycline hyclate	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	4