doxycycline

Product NDC: 48433-158
11-digit product format: 484330158
Labeler code: 48433
Product ID: 48433-158_5bb37e2c-c178-789c-e063-6394a90a788b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA205115
Marketing category: ANDA
Marketing start: 2026-09-02
Substance: DOXYCYCLINE
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205115-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18
A205115-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205115-001	AB
A205115-002	AB
A205115-003	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 4 · 129 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	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB	2016-02-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A205115-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205115-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205115-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205115-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205115-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205115-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205115-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205115-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205115-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205115-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205115-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205115-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205115-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205115-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205115-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205115-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205115-001	AB	1	`301d65b070ca…`

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	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Coupler LLC	595470f9-2004-c378-e063-6294a90a3415	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	7028b7f9-21cd-4c8e-97aa-a3e7d849939b	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	PD-Rx Pharmaceuticals, Inc.	dedebcb4-3c3f-4487-a488-36af12640c92	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	A-S Medication Solutions	2c7795c9-9e4e-477a-ad9f-01e4c55c06b6	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	AvPAK	a5b28a41-db12-af7c-e053-2995a90ace09	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	fef9580d-8850-4cbb-89eb-2b4d40ee59c9	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	aa01035d-8b4a-4fdc-bfdf-2b39df0d8fc9	2024-11-28		Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	5f989cc1-48ae-41bb-b297-2f8c83760b6d	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115
doxycycline	DOXYCYCLINE	Proficient Rx LP	f3ba6c30-ada3-4a57-9ff8-30558202b9aa	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205115 application number: ANDA205115

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
48433-158-03	48433015803	30 BLISTER PACK in 1 CARTON (48433-158-03) / 1 CAPSULE in 1 BLISTER PACK (48433-158-01)	30 blister pack	2026-09-02	No	No	Current