Doxycycline Hyclate

Product NDC: 59115-123
11-digit product format: 591150123
Labeler code: 59115
Product ID: 59115-123_749d60f9-44ef-4609-a4da-4ba1d8140447
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceutical
Application: ANDA062396
Marketing category: ANDA
Marketing start: 1990-09-01
Substance: DOXYCYCLINE HYCLATE
Active strength: 50 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062396-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07
A062396-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062396-001	AB
A062396-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062396-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	AB	1	`782e0a99824c…`

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	50 mg/1

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	52ba329a-8cb3-cf30-e063-6394a90aa0dc	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f309ccbb-b68a-3190-e053-2995a90a0ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	c4aae81f-0219-450f-aa60-953964f74172	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	8c525e4e-6e1b-4579-e053-2a95a90a43da	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	e98d11b0-535f-4e57-9639-6358835c04bc	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline	DOXYCYCLINE	Direct_Rx	8c273efa-62ec-16b2-e053-2995a90ac41d	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	214e5a5c-7f3e-478b-93d3-1713de9e7672	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396

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
59115-123-05	59115012305	500 CAPSULE in 1 BOTTLE, PLASTIC (59115-123-05)	500 capsule	1990-09-01	0000-00-00	No	No	Current
59115-123-50	59115012350	50 CAPSULE in 1 BOTTLE, PLASTIC (59115-123-50)	50 capsule	1990-09-01	0000-00-00	No	No	Current