Doxycycline

Product NDC: 82804-171
Requested package NDC: 82804-171-20
11-digit product format: 828040171
Labeler code: 82804
Product ID: 82804-171_36c5a6da-cfa8-4fc1-88f4-970dce541965
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA209165
Marketing category: ANDA
Marketing start: 2017-07-31
Substance: DOXYCYCLINE
Active strength: 100 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
A209165-001	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2017-07-28
A209165-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2017-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209165-001	AB
A209165-002	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	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`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	A209165-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209165-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209165-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209165-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209165-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209165-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209165-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209165-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209165-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209165-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209165-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209165-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209165-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209165-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209165-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209165-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209165-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209165-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209165-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209165-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209165-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209165-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209165-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209165-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209165-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209165-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209165-002	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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	100 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
1649990	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
d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	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
82804-171-06	Doxycycline	6 in 1 BOTTLE	CAPSULE	6	2
82804-171-14	Doxycycline	14 in 1 BOTTLE	CAPSULE	14	2
82804-171-20	Doxycycline	20 in 1 BOTTLE	CAPSULE	20	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-171-20	EA - Each	82804-171	7461bc74-a41d-4e1e-bb48-e7be5a25f59e	1	2026-02-05

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165
Doxycycline	DOXYCYCLINE	Proficient Rx LP	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165 ndc (package): 82804-171-20 ndc (product): 82804-171 ndc11 (package): 82804017120
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Inc.	d77e2a9c-c536-4e66-b87a-40b085737699	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165
Doxycycline	DOXYCYCLINE	Alembic Pharmaceuticals Limited	3dfa486c-4665-4882-93ac-9259708f899c	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-171-20	82804017120	20 CAPSULE in 1 BOTTLE (82804-171-20)	20 capsule	2025-06-19	No	No	Current