Doxycycline Hyclate

Product NDC: 69668-515
11-digit product format: 696680515
Labeler code: 69668
Product ID: 69668-515_6ce404bd-62b7-4aeb-e053-2a91aa0ade68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE HYCLATE
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Sonoma Pharmaceuticals, Inc.
Application: ANDA207494
Marketing category: ANDA
Marketing start: 2016-11-28
Substance: DOXYCYCLINE HYCLATE
Active strength: 150 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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	TE codes	Approval date
A207494-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15
A207494-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15
A207494-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207494-001	AB
A207494-002	AB
A207494-003	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 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-002	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2019-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207494-001	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 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	A207494-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207494-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207494-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207494-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207494-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207494-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207494-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207494-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207494-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207494-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207494-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207494-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207494-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207494-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207494-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207494-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207494-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline Hyclate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
799048	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4fa26176-a730-48ed-9659-e2f64212f418	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69668-515-30	Doxycycline Hyclate	30 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69668-515-30	EA - Each	69668-515	e5c5cfeb-31bf-4f4f-900f-1bbb63c17126	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69668-515	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [SONOMA PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20181103_4fa26176-a730-48ed-9659-e2f64212f418.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Solco Healthcare US LLC	0a18d4c7-9484-4d3e-b61b-e81fe63fefec	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207494 application number: ANDA207494
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sonoma Pharmaceuticals, Inc.	4fa26176-a730-48ed-9659-e2f64212f418	2018-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207494 application number: ANDA207494 ndc (product): 69668-515

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
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	PSN	4fa26176-a730-48ed-9659-e2f64212f418	3
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	SCD	4fa26176-a730-48ed-9659-e2f64212f418	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69668-515-30	69668051530	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69668-515-30)	2018-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate	Sonoma Pharmaceuticals, Inc. \| PD-Rx Pharmaceuticals, Inc.	2018-05-23	HUMAN PRESCRIPTION DRUG LABEL	3