doxycycline

Product NDC: 60760-721
11-digit product format: 607600721
Labeler code: 60760
Product ID: 60760-721_50c3fdb2-97a0-1143-e063-6294a90a90df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA209402
Marketing category: ANDA
Marketing start: 2021-11-19
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	60760-721	60760-721-20	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
A209402-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209402-001	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.

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	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209402-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209402-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209402-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209402-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209402-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209402-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209402-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209402-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209402-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209402-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209402-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209402-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209402-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209402-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209402-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209402-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209402-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209402-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209402-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209402-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209402-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209402-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209402-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209402-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209402-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209402-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209402-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209402-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209402-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209402-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209402-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209402-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209402-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209402-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209402-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209402-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209402-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209402-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209402-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	bcc95094-80ed-4023-b2a6-955a4810bfbe	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	d3c0b756-30ba-4ef9-a178-fd785d720373	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	ST. MARY'S MEDICAL PARK PHARMACY	00b2aa98-dea2-90c3-e063-6294a90a35d6	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402 ndc (product): 60760-721
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	7f882f1a-fe75-4592-9df5-f0e4bf1d232e	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	A-S Medication Solutions	1c998ca8-1df6-4b3c-9533-f4500cc1079a	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Cranbury Pharmaceuticals, LLC	43ceb0ee-268a-424c-a6a8-88e824c5ed04	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Diirect_rx	1b403f4b-1c61-3991-e063-6394a90ae4f2	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	1df9e905-d2e7-4a5a-8bd6-43f4850ba900	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Proficient Rx LP	716dccec-7480-44dd-91b9-249ae2c25088	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	Asclemed USA, Inc.	f33ae6f5-bdb6-4c15-9e62-6180433bb1fb	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402

Additional Listing Data#

Finished product: Yes
Brand name base: doxycycline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 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
1649988	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
00b2aa98-dea2-90c3-e063-6294a90a35d6	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60760-721-20	doxycycline	20 in 1 BOTTLE, PLASTIC	CAPSULE	20		3
60760-721-60	doxycycline	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-721-20	EA - Each	60760-721	e5575335-183f-4344-b2ec-9bda903c3cfa	1	2023-08-08
60760-721-60	EA - Each	60760-721	c6d02a69-1f42-40e9-b949-887865b48b66	1	2026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-721	DOXYCYCLINE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]	1	Current NDC, 2 package rows	20230718_00b2aa98-dea2-90c3-e063-6294a90a35d6.zip

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
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	00b2aa98-dea2-90c3-e063-6294a90a35d6	3
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	00b2aa98-dea2-90c3-e063-6294a90a35d6	3
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	00b2aa98-dea2-90c3-e063-6294a90a35d6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-721-20	60760072120	20 in 1 BOTTLE, PLASTIC					Historical
60760-721-60	60760072160	60 CAPSULE in 1 BOTTLE, PLASTIC (60760-721-60)	60 capsule	2026-01-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxycycline hyclate capsules	ST. MARY'S MEDICAL PARK PHARMACY	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	3