DOXYCYCLINE

Product NDC: 61919-276
11-digit product format: 619190276
Labeler code: 61919
Product ID: 61919-276_4c4a0016-0fb6-1dc9-e063-6294a90a9541
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA204446
Marketing category: ANDA
Marketing start: 2016-03-17
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

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-276-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-276-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-276-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-276-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-276-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-276-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-276-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-276-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-276-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: 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
31512ece-cb16-2a9a-e054-00144ff88e88	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-276-20	2025-01-30	C162847	48780-1	2cef2736-6755-d83d-e063-dadaa90ab31f	DOXYCYCLINE MONOHYDRATE 100mg 20CAPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-276-20	DOXYCYCLINE	20 in 1 BOTTLE	CAPSULE	20		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-276-20	EA - Each	61919-276	9bd207cb-a68b-4321-acbe-0ded95f4b7b3	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-276	DOXYCYCLINE CAPSULE DOXYCYCLINE MONOHYDRATE CAPSULE [DIRECT RX]	4	Current NDC, Legacy NDC, 1 package rows	20230113_31512ece-cb16-2a9a-e054-00144ff88e88.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 ndc (product): 61919-276
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

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	31512ece-cb16-2a9a-e054-00144ff88e88	5
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	31512ece-cb16-2a9a-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-276-20	61919027620	20 CAPSULE in 1 BOTTLE (61919-276-20)	20 capsule	2016-03-17	0000-00-00	No	No	Current