Doxycycline

Product NDC: 67296-1570
Requested package NDC: 67296-1570-3
11-digit product format: 672961570
Labeler code: 67296
Product ID: 67296-1570_d61c027e-f4ea-61ec-e053-2995a90afc82
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA209165
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: DOXYCYCLINE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1570	67296-1570-3	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209165-001	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB	2017-07-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209165-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	2017-07-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A209165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209165-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209165-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209165-002	AB	1	`782e0a99824c…`

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
67296-1570-1	2024-01-30	C162847	48780-1	1030e365-5b69-111a-e063-dadaa90a10e2	doxycycline
67296-1570-2	2024-01-30	C162847	48780-1	1030e365-5b69-111a-e063-dadaa90a10e2	doxycycline
67296-1570-3	2024-01-30	C162847	48780-1	1030e365-5b69-111a-e063-dadaa90a10e2	doxycycline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1570-1	Doxycycline	14 in 1 BOTTLE	CAPSULE	14	4
67296-1570-2	Doxycycline	20 in 1 BOTTLE	CAPSULE	20	4
67296-1570-3	Doxycycline	28 in 1 BOTTLE	CAPSULE	28	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1570	DOXYCYCLINE CAPSULE [REDPHARM DRUG, INC.]	4	Legacy NDC, 3 package rows	20220122_68187cd7-79f5-17b0-e053-2a91aa0a05f1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Proficient Rx LP	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209165 application number: ANDA209165
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	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2024-12-24	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	68187cd7-79f5-17b0-e053-2a91aa0a05f1	4
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	68187cd7-79f5-17b0-e053-2a91aa0a05f1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1570-3	67296157003	28 CAPSULE in 1 BOTTLE (67296-1570-3)	28 capsule	2018-01-01	0000-00-00	No	No	Current