Doxycycline

Product NDC: 50090-3809
11-digit product format: 500903809
Labeler code: 50090
Product ID: 50090-3809_d542f20c-a672-43c6-a9dc-982a906d39c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA209582
Marketing category: ANDA
Marketing start: 2018-01-11
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209582-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28
A209582-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209582-001	AB
A209582-002	AB
A209582-003	AB
A209582-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209582-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB	2017-09-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB	2017-09-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB	2017-09-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	2017-09-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209582-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209582-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	55873d3e-09c4-4726-acfe-5da581589575	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582 ndc (product): 50090-3809
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	b46208a2-5072-4df5-b2af-379f865545d2	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	bc321932-b600-4659-a499-1853991b4ab9	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline Monohydrate	DOXYCYCLINE MONOHYDRATE	Advanced Rx Pharmacy of Tennessee, LLC	f91373f2-c57b-f1f1-e053-6294a90a7bdd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	c886b2e4-494a-4325-abaf-981fc3d01c66	2024-11-28		Exact identifier application applno (ANDA): 209582 application number: ANDA209582
Doxycycline	DOXYCYCLINE	Proficient Rx LP	b83c4c4b-2885-43e7-b1c9-0b3bbf75528d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209582 application number: ANDA209582

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
1650142	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
55873d3e-09c4-4726-acfe-5da581589575	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
50090-3809-0	2023-02-07	C162847	48780-1	f386c649-c649-0266-e053-dadaa90a7c1a	Doxycycline Tablets, USP
50090-3809-0	2023-01-30	C162847	48780-1	f386c649-c649-0266-e053-dadaa90a7c1a	Doxycycline Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3809-0	Doxycycline	20 in 1 BOTTLE	TABLET, FILM COATED	20		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3809-0	EA - Each	50090-3809	ba60c1ab-ca45-4b3b-9ee4-1c1dadb0b73c	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3809	DOXYCYCLINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	6	Current NDC, Legacy NDC, 1 package rows	20240108_55873d3e-09c4-4726-acfe-5da581589575.zip

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
1650142	doxycycline monohydrate 100 MG Oral Tablet	PSN	55873d3e-09c4-4726-acfe-5da581589575	8
1650142	doxycycline monohydrate 100 MG Oral Tablet	SCD	55873d3e-09c4-4726-acfe-5da581589575	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3809-0	50090380900	20 TABLET, FILM COATED in 1 BOTTLE (50090-3809-0)	2018-11-12	0000-00-00	No	No	Current