Doxycycline

Product NDC: 85776-300
Requested package NDC: 85776-300-60
11-digit product format: 857760300
Labeler code: 85776
Product ID: 85776-300_575c46be-1210-fb40-e063-6294a90a8d0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Wellhouse Pharma, LLC
Application: NDA050641
Marketing category: NDA
Marketing start: 2022-02-17
Substance: DOXYCYCLINE
Active strength: 150 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050641-001	MONODOX	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29
N050641-002	MONODOX	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10
N050641-003	MONODOX	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18
N050641-004	MONODOX	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N050641-001	AB
N050641-002	AB
N050641-003	AB
N050641-004	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 5 · 162 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
2026-09-14 22:38:34	2026-08	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	MONODOX	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	MONODOX	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	1992-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	MONODOX	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2006-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	MONODOX	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2022-02-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	N050641-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050641-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050641-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050641-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050641-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050641-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050641-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050641-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050641-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050641-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050641-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050641-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050641-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050641-004	AB	1	`5bbf6a4d5a75…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N12000U13O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
728207	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
57f97f68-11fb-4900-9efb-ca3b00818d8e	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641 ndc (package): 85776-300-60 ndc (product): 85776-300 ndc11 (package): 85776030060
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Chartwell RX, LLC.	02aa8731-d40f-43d8-8b63-a79a0503f8db	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050641 application number: NDA050641

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85776-300-60	85776030060	60 CAPSULE in 1 BOTTLE (85776-300-60)	60 capsule	2026-07-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Capsules, USP Rx Only	Wellhouse Pharma, LLC	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1