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…`

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 · 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

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

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