Doxycycline

Product NDC: 43386-790
11-digit product format: 433860790
Labeler code: 43386
Product ID: 43386-790_a3ed2ee4-163c-4167-abf2-59a7e1d66a61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA204446
Marketing category: ANDA
Marketing start: 2015-07-08
Substance: DOXYCYCLINE
Active strength: 50 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	43386-790-01
excluded package	package	43386-790-10
excluded package	package	43386-790-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A204446-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28
A204446-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28
A204446-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204446-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204446-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204446-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204446-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204446-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204446-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204446-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204446-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204446-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204446-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204446-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204446-001	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	50 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
700408	Internal RxNorm lookup
1649401	Internal RxNorm lookup
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
6512bf22-c211-4127-a8c8-2419656580f6	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
43386-790-01	Doxycycline	100 in 1 BOTTLE	CAPSULE	100	4
43386-790-10	Doxycycline	1000 in 1 BOTTLE	CAPSULE	1000	4
43386-790-11	Doxycycline	50 in 1 BOTTLE	CAPSULE	50	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-790-01	EA - Each	43386-790	c7cac30c-2271-4f2c-9631-a4ca65ec1466	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-790	DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240131_6512bf22-c211-4127-a8c8-2419656580f6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	DIRECT RX	31512ece-cb16-2a9a-e054-00144ff88e88	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204446 application number: ANDA204446
Doxycycline	DOXYCYCLINE	Lupin Pharmaceuticals,Inc.	6512bf22-c211-4127-a8c8-2419656580f6	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204446 application number: ANDA204446 ndc (product): 43386-790

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	6512bf22-c211-4127-a8c8-2419656580f6	4
1649401	doxycycline monohydrate 50 MG Oral Capsule	PSN	6512bf22-c211-4127-a8c8-2419656580f6	4
700408	doxycycline monohydrate 75 MG Oral Capsule	PSN	6512bf22-c211-4127-a8c8-2419656580f6	4
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	6512bf22-c211-4127-a8c8-2419656580f6	4
1649401	doxycycline monohydrate 50 MG Oral Capsule	SCD	6512bf22-c211-4127-a8c8-2419656580f6	4
700408	doxycycline monohydrate 75 MG Oral Capsule	SCD	6512bf22-c211-4127-a8c8-2419656580f6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-790-01	43386079001	100 CAPSULE in 1 BOTTLE (43386-790-01)	100 capsule	2015-07-08	0000-00-00	No	No	Current
43386-790-10	43386079010	1000 CAPSULE in 1 BOTTLE (43386-790-10)	1000 capsule	2015-07-08	0000-00-00	No	No	Current
43386-790-11	43386079011	50 CAPSULE in 1 BOTTLE (43386-790-11)	50 capsule	2015-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Capsules, USP Rx only	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	4