Doxycycline hyclate

Product NDC: 82804-316
11-digit product format: 828040316
Labeler code: 82804
Product ID: 82804-316_b0686eca-8bef-4e0d-a160-7b2c265f1b44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA207774
Marketing category: ANDA
Marketing start: 2022-01-10
Substance: DOXYCYCLINE HYCLATE
Active strength: 50 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207774-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2018-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207774-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2018-05-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207774-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207774-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207774-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207774-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	df44c686-de34-487a-8741-a0a12993cab2	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207774 application number: ANDA207774
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	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

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	Sample	Exclude flag	Status
82804-316-20	82804031620	20 CAPSULE in 1 BOTTLE (82804-316-20)	20 capsule	2026-09-16	No	No	Current