Doxycycline Hyclate

Product NDC: 60760-651
11-digit product format: 607600651
Labeler code: 60760
Product ID: 60760-651_e6731e26-9dae-37fc-e053-2a95a90a2b29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA207773
Marketing category: ANDA
Marketing start: 2022-08-09
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60760-651		D	Discontinued by firm	2026-08-03
excluded package	package	60760-651	60760-651-20	D	Discontinued by firm	2026-08-03
excluded package	package	60760-651	60760-651-60	D	Discontinued by firm	2026-08-03

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
A207773-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207773-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`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	A207773-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-651-20	EA - Each	60760-651	a10d71f0-8a05-47f0-9902-67fd18adefd9	1	2022-10-06
60760-651-60	EA - Each	60760-651	3e371fd7-8cd3-4fda-8646-3bdc8946ace8	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-651	DOXYCYCLINE HYCLATE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]	1	Legacy NDC	20220820_e6731de6-acc5-3369-e053-2995a90a8b4a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	RedPharm Drug, Inc.	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	763997f0-b35c-43cb-a792-3e0bae589536	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	5b4390ed-a0ec-4ef8-864c-8a33a83653f9	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NCS HealthCare of KY, LLC dba Vangard Labs	104cac0f-7c99-4faf-ba08-0159ed767a3e	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	68b3aba5-f1e4-4cdf-b244-0302aa8595fe	2024-08-16		Exact identifier application applno (ANDA): 207773 application number: ANDA207773

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
60760-651-20	60760065120	20 TABLET in 1 BOTTLE, PLASTIC (60760-651-20)	20 tablet	2022-08-09	0000-00-00	No	No	Current
60760-651-60	60760065160	60 TABLET in 1 BOTTLE, PLASTIC (60760-651-60)	60 tablet	2022-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Tablets, USP	ST. MARY'S MEDICAL PARK PHARMACY	2022-08-17	HUMAN PRESCRIPTION DRUG LABEL	1