doxycycline

Product NDC: 68071-2761
11-digit product format: 680712761
Labeler code: 68071
Product ID: 68071-2761_2a8151c6-4f94-13d9-e063-6394a90a6c59
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
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: 2026-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2761		D	Discontinued by firm	2026-08-17
excluded package	package	68071-2761	68071-2761-2	D	Discontinued by firm	2026-08-17
excluded package	package	68071-2761	68071-2761-3	D	Discontinued by firm	2026-08-17
excluded package	package	68071-2761	68071-2761-4	D	Discontinued by firm	2026-08-17
excluded package	package	68071-2761	68071-2761-6	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
2026-08-18 06:07:40	2026-07	A209402-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-10-07	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A209402-001	AB	1	`caaa826d4ba7…`
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…`

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	SPL version
68071-2761-2	doxycycline	2 in 1 BOTTLE	CAPSULE	2	5
68071-2761-3	doxycycline	3 in 1 BOTTLE	CAPSULE	3	5
68071-2761-4	doxycycline	4 in 1 BOTTLE	CAPSULE	4	5
68071-2761-6	doxycycline	6 in 1 BOTTLE	CAPSULE	6	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2761	DOXYCYCLINE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 4 package rows	20250101_e1929645-2cca-7f9d-e053-2a95a90a6d85.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209402 application number: ANDA209402
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	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
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 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

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	e1929645-2cca-7f9d-e053-2a95a90a6d85	5
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	e1929645-2cca-7f9d-e053-2a95a90a6d85	5
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	e1929645-2cca-7f9d-e053-2a95a90a6d85	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2761-2	68071276102	2 CAPSULE in 1 BOTTLE (68071-2761-2)	2 capsule	2022-06-16	0000-00-00	No	No	Current
68071-2761-3	68071276103	3 CAPSULE in 1 BOTTLE (68071-2761-3)	3 capsule	2022-06-16		No	No	Historical
68071-2761-4	68071276104	4 CAPSULE in 1 BOTTLE (68071-2761-4)	4 capsule	2022-06-16	0000-00-00	No	No	Current
68071-2761-6	68071276106	6 CAPSULE in 1 BOTTLE (68071-2761-6)	6 capsule	2022-06-16		No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
doxycycline hyclate capsules	NuCare Pharmaceuticals,Inc.	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	5