Doxycycline

Product NDC: 62135-725
11-digit product format: 621350725
Labeler code: 62135
Product ID: 62135-725_45899031-dfb9-a7d6-e063-6294a90a80c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA091605
Marketing category: ANDA
Marketing start: 2012-05-01
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

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	RLD / RS	Approval date
A091605-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20
A091605-004	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091605-001	AB
A091605-002	AB
A091605-003	AB
A091605-004	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.

Product history page 1 of 5 · 164 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	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091605-001	DOXYCYCLINE	EQ 50MG BASE	TABLET / ORAL	AB		2011-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-002	DOXYCYCLINE	EQ 75MG BASE	TABLET / ORAL	AB		2011-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-003	DOXYCYCLINE	EQ 100MG BASE	TABLET / ORAL	AB		2011-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-004	DOXYCYCLINE	EQ 150MG BASE	TABLET / ORAL	AB	RS	2011-12-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A091605-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091605-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091605-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091605-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091605-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091605-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091605-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091605-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091605-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091605-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091605-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091605-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091605-004	AB	1	`d06236e962d9…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1650142	Internal RxNorm lookup
1652673	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
5bebf320-1395-43b9-9404-fe479d70b240	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	Strength	SPL version
62135-725-20	Doxycycline	20 in 1 BOTTLE	TABLET	20		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-725-20	EA - Each	62135-725	9f6f1823-c9c5-4127-ac26-476059ef7103	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-725	DOXYCYCLINE TABLET [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241012_5bebf320-1395-43b9-9404-fe479d70b240.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Proficient Rx LP	112c35d6-a397-45de-a57a-6e687cb27b4f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	Northwind Health Company, LLC	f2f1ee15-9323-1263-e053-2995a90a01fa	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	Chartwell RX, LLC	5bebf320-1395-43b9-9404-fe479d70b240	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605 ndc (product): 62135-725
Doxycycline	DOXYCYCLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2bcde264-5f6f-47f6-ae2e-1b7010deacf7	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	2b3b3c48-eb60-400c-bdfe-50635a136c90	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091605 application number: ANDA091605

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	5bebf320-1395-43b9-9404-fe479d70b240	3
1652673	doxycycline monohydrate 50 MG Oral Tablet	PSN	5bebf320-1395-43b9-9404-fe479d70b240	3
1650142	doxycycline monohydrate 100 MG Oral Tablet	SCD	5bebf320-1395-43b9-9404-fe479d70b240	3
1652673	doxycycline monohydrate 50 MG Oral Tablet	SCD	5bebf320-1395-43b9-9404-fe479d70b240	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-725-20	62135072520	20 TABLET in 1 BOTTLE (62135-725-20)	20 tablet	2023-07-27	No	No	Current