Doxycycline

Product NDC: 64380-923
11-digit product format: 643800923
Labeler code: 64380
Product ID: 64380-923_9b0540f1-2441-44c2-8ae2-b048574c1790
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxycycline
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA065055
Marketing category: ANDA
Marketing start: 2022-08-01
Substance: DOXYCYCLINE
Active strength: 150 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 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065055-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065055-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065055-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065055-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	150 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
700408	Internal RxNorm lookup
728207	Internal RxNorm lookup
1649401	Internal RxNorm lookup
1649990	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
d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	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
64380-923-01	Doxycycline	60 in 1 BOTTLE	CAPSULE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-923-01	EA - Each	64380-923	d2b5541a-eccb-4819-b105-32c60cb037fb	1	2026-01-08

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 ndc (product): 64380-923
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
728207	doxycycline monohydrate 150 MG Oral Capsule	PSN	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
1649401	doxycycline monohydrate 50 MG Oral Capsule	PSN	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
700408	doxycycline monohydrate 75 MG Oral Capsule	PSN	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
728207	doxycycline monohydrate 150 MG Oral Capsule	SCD	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
1649401	doxycycline monohydrate 50 MG Oral Capsule	SCD	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2
700408	doxycycline monohydrate 75 MG Oral Capsule	SCD	d27c58a1-5c99-4007-9bc6-ad9b6fb56db8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64380-923-01	64380092301	60 CAPSULE in 1 BOTTLE (64380-923-01)	60 capsule	2025-09-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Capsules, USP Rx only	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd. \| Strides Alathur Private Limited	2025-09-03	HUMAN PRESCRIPTION DRUG LABEL	2