Doxycycline hyclate

Product NDC: 70771-1359
Requested package NDC: 70771-1359-5
11-digit product format: 707711359
Labeler code: 70771
Product ID: 70771-1359_cb5b26e1-ae6e-46a2-9edd-e3e98ced7a6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA207774
Marketing category: ANDA
Marketing start: 2018-09-12
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207774-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		2018-05-31
A207774-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2018-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207774-001	AB
A207774-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`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	A207774-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207774-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207774-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207774-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207774-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207774-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207774-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207774-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207774-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207774-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207774-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207774-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207774-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207774-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207774-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207774-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207774-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207774-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207774-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207774-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207774-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207774-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207774-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207774-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207774-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207774-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207774-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207774-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207774-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207774-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207774-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207774-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207774-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207774-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207774-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207774-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207774-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207774-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207774-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207774-002	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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1649405	Internal RxNorm lookup
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
fc8213e3-e546-495f-ac2c-3856db79c6e1	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	SPL version
70771-1359-0	Doxycycline hyclate	1000 in 1 BOTTLE	CAPSULE	1000	6
70771-1359-1	Doxycycline hyclate	100 in 1 BOTTLE	CAPSULE	100	6
70771-1359-2	Doxycycline hyclate	10 in 1 BLISTER PACK	CAPSULE	10	6
70771-1359-4	Doxycycline hyclate	10 in 1 CARTON	CAPSULE	10	6
70771-1359-5	Doxycycline hyclate	500 in 1 BOTTLE	CAPSULE	500	6
70771-1359-7	Doxycycline hyclate	50 in 1 BOTTLE	CAPSULE	50	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1359	DOXYCYCLINE HYCLATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 6 package rows	20240821_fc8213e3-e546-495f-ac2c-3856db79c6e1.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	bea36ec9-f7fd-4295-bfbd-0228cffcddd7	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Sportpharm LLC	45c4b584-b7e2-4e91-a93d-aff14feb606f	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	51d245a3-ef51-474a-bc91-377d5f42dde3	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b612d2f5-b703-47f0-b5eb-b66a7aeed577	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Asclemed USA, Inc.	bed39bae-64c2-44b4-9c95-682ead4e6738	2025-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	65b3a0e2-32a5-436a-b805-854fbffcb611	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	30b041a0-8f5f-4d9f-b11b-106f7432955b	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	fc8213e3-e546-495f-ac2c-3856db79c6e1	2024-08-16		Exact identifier application applno (ANDA): 207774 application number: ANDA207774 ndc (package): 70771-1359-5 ndc (product): 70771-1359 ndc11 (package): 70771135905

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	fc8213e3-e546-495f-ac2c-3856db79c6e1	6
1649405	doxycycline hyclate 50 MG Oral Capsule	PSN	fc8213e3-e546-495f-ac2c-3856db79c6e1	6
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	fc8213e3-e546-495f-ac2c-3856db79c6e1	6
1649405	doxycycline hyclate 50 MG Oral Capsule	SCD	fc8213e3-e546-495f-ac2c-3856db79c6e1	6
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	fc8213e3-e546-495f-ac2c-3856db79c6e1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1359-5	70771135905	500 CAPSULE in 1 BOTTLE (70771-1359-5)	500 capsule	2018-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline hyclate capsules	Zydus Lifesciences Limited	2024-08-16	HUMAN PRESCRIPTION DRUG LABEL	6