Doxycycline

Product NDC: 63187-135
Requested package NDC: 63187-135-14
11-digit product format: 631870135
Labeler code: 63187
Product ID: 63187-135_305c2440-855c-4b18-b542-75ae99e2deee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA065055
Marketing category: ANDA
Marketing start: 2000-12-01
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: 2022-12-31
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	63187-135	63187-135-14	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	63187-135	63187-135-14	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-135	63187-135-14	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065055-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01
A065055-002	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01
A065055-003	DOXYCYCLINE	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15
A065055-004	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065055-001	AB
A065055-002	AB
A065055-003	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 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	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`d06236e962d9…`

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	A065055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065055-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065055-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065055-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065055-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065055-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065055-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065055-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065055-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065055-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065055-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065055-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065055-001	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
63187-135-20	EA - Each	63187-135	0bd2c61d-f594-4f61-9bd7-273862bbd470	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-135	DOXYCYCLINE CAPSULE [PROFICIENT RX LP]	6	Legacy NDC	20210121_428723a2-5c52-4505-8250-1fb74b846684.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	04de98f3-33a2-48ba-85b5-9fac867524b7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Golden State Medical Supply, Inc.	e9997efa-9ad8-3870-e053-2a95a90a1ac3	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	9e710113-f25e-46fb-8327-7a8e649613a2	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	American Health Packaging	e49f8ff9-af7a-47eb-929b-238cff381c03	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	American Health Packaging	3fbf4bb8-036e-41d3-9628-476fc05ddd31	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	6285181d-e34d-4def-abe6-2c41254ada75	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	fa1da527-7a0f-8ed6-e053-6394a90a1b62	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	Proficient Rx LP	c707566b-dbc7-4dac-bad1-952f2f4d6845	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	6aab6fee-791e-4141-b55f-685ec9d8712a	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065055 application number: ANDA065055

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
63187-135-14	63187013514	14 CAPSULE in 1 BOTTLE (63187-135-14)	14 capsule	2019-01-01	0000-00-00	No	No	Current