Doxycycline

Product NDC: 64380-921
11-digit product format: 643800921
Labeler code: 64380
Product ID: 64380-921_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: 75 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
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 4 · 152 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
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	AB		2000-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-002	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	AB		2000-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-003	DOXYCYCLINE	EQ 150MG BASE	CAPSULE / ORAL	AB	RS	2005-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065055-004	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL			2005-04-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-05-31 18:47 UTC	2024-05	A065055-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065055-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065055-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065055-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065055-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065055-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065055-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065055-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065055-001	AB	1	`4b0b4de00fa7…`

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 · 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): 64380-921
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE	75 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
64380-921-01	Doxycycline	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		2

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
64380-921-01	64380092101	100 CAPSULE in 1 BOTTLE, PLASTIC (64380-921-01)	100 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