Doxycycline Hyclate

Product NDC: 60219-1100
Requested package NDC: 60219-1100-1
11-digit product format: 602191100
Labeler code: 60219
Product ID: 60219-1100_d114fe27-0716-4e35-be8d-e69bd5a3cbb5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA207289
Marketing category: ANDA
Marketing start: 2016-06-28
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

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
A207289-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207289-001	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	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207289-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-06-27	`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	A207289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207289-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207289-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207289-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207289-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207289-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207289-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207289-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207289-001	AB	1	`cb3db0bc1861…`

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	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
49ecbf95-58e8-4f3c-b5d5-650a15d866cb	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
60219-1100-1	Doxycycline Hyclate	100 in 1 BOTTLE	CAPSULE	100		13
60219-1100-3	Doxycycline Hyclate	20 in 1 BOTTLE	CAPSULE	20		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1100	DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	12	Current NDC, Legacy NDC, 2 package rows	20231229_49ecbf95-58e8-4f3c-b5d5-650a15d866cb.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	Bryant Ranch Prepack	f9a9a558-4063-4aa7-9191-3875c97cf49a	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289 ndc (package): 60219-1100-1 ndc (product): 60219-1100 ndc11 (package): 60219110001
Doxycycline Hyclate	DOXYCYCLINE	Amneal Pharmaceuticals NY LLC	79f3c026-7687-4a11-8d2e-03493531d3bf	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	b4f2ab4f-c32b-6435-e053-2995a90a69b6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289
Doxycycline Hyclate	DOXYCYCLINE	Proficient Rx LP	e2151005-fb4a-485d-88ad-b44c4594d579	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207289 application number: ANDA207289

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	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	13
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	13
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	49ecbf95-58e8-4f3c-b5d5-650a15d866cb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1100-1	60219110001	100 CAPSULE in 1 BOTTLE (60219-1100-1)	100 capsule	2016-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Capsules, USP (100 mg) Rx only	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	13