Doxycycline

Product NDC: 72789-047
Requested package NDC: 72789-047-02
11-digit product format: 727890047
Labeler code: 72789
Product ID: 72789-047_e71668ac-7b55-3bcb-e053-2995a90a5d5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065053
Marketing category: ANDA
Marketing start: 2000-12-26
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	72789-047	72789-047-02	D	Discontinued by firm		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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-047	72789-047-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72789-047	72789-047-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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	RLD / RS	Approval date
A065053-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22
A065053-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22
A065053-003	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065053-001	AB
A065053-002	AB
A065053-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	2000-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-003	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065053-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-11-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A065053-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065053-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065053-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065053-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065053-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065053-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065053-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065053-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065053-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065053-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065053-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065053-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065053-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065053-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065053-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065053-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065053-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-047-02	EA - Each	72789-047	c16266dc-fffb-4cb8-b7c7-500144d462d0	1	2020-02-13
72789-047-14	EA - Each	72789-047	0e873152-8fbe-4561-845a-649570a78305	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-047	DOXYCYCLINE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	17	Legacy NDC	20240719_9f200384-d271-46dd-9350-8a71c8d8910a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Sun Pharmaceutical Industries, Inc.	829dbd3d-5c2b-47b8-96a5-423af78c93b9	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Direct_Rx	dfef600c-bceb-fbc9-e053-2a95a90ae6c0	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	4b170180-21f4-4ee5-9e81-1607ab52cfca	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065053 application number: ANDA065053

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	Marketing end	Sample	Exclude flag	Status
72789-047-02	72789004702	2 CAPSULE in 1 BOTTLE, PLASTIC (72789-047-02)	2 capsule	2020-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Package/Label Display Panel	PD-Rx Pharmaceuticals, Inc.	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	18