Doxycycline Hyclate

Product NDC: 0143-9803
11-digit product format: 001439803
Labeler code: 0143
Product ID: 0143-9803_bc3351b4-baf4-455a-9b12-162da800c25d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA062396
Marketing category: ANDA
Marketing start: 1984-05-07
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062396-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07
A062396-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062396-001	AB
A062396-002	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 3 · 82 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	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062396-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1649405	Internal RxNorm lookup
1649988	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
4ec4c8ca-ce83-4948-8626-21eb82ae5c19	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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9803-05	Doxycycline Hyclate	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		50
0143-9803-50	Doxycycline Hyclate	50 in 1 BOTTLE, PLASTIC	CAPSULE	50		50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9803-05	EA - Each	0143-9803	0a9b4f32-0d60-4e04-acc0-3e2250605a37	1	2013-03-03
0143-9803-50	EA - Each	0143-9803	0a6b2827-0023-422a-b3c1-03bbece5aedc	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
DIACETYLATED MONOGLYCERIDES	INACTIVE INGREDIENT	5Z17386USF	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]	12
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]	8
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9803	DOXYCYCLINE HYCLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]	48	Current NDC, Legacy NDC, 2 package rows	20250515_4ec4c8ca-ce83-4948-8626-21eb82ae5c19.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	52ba329a-8cb3-cf30-e063-6394a90aa0dc	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f309ccbb-b68a-3190-e053-2995a90a0ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	c4aae81f-0219-450f-aa60-953964f74172	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	8c525e4e-6e1b-4579-e053-2a95a90a43da	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	e98d11b0-535f-4e57-9639-6358835c04bc	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396 ndc (product): 0143-9803
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline	DOXYCYCLINE	Direct_Rx	8c273efa-62ec-16b2-e053-2995a90ac41d	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	214e5a5c-7f3e-478b-93d3-1713de9e7672	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	50
1649405	doxycycline hyclate 50 MG Oral Capsule	PSN	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	50
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	50
1649405	doxycycline hyclate 50 MG Oral Capsule	SCD	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	50
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	50
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	5f523294-e62b-4da5-8799-047d4bed966f	48
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	5f523294-e62b-4da5-8799-047d4bed966f	48
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	5f523294-e62b-4da5-8799-047d4bed966f	48
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	e24a3292-0d4f-4692-8cf7-a82bd19e5932	29
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	e24a3292-0d4f-4692-8cf7-a82bd19e5932	29
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	e24a3292-0d4f-4692-8cf7-a82bd19e5932	29
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	25
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	25
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	25
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	c4aae81f-0219-450f-aa60-953964f74172	17
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	c4aae81f-0219-450f-aa60-953964f74172	17
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	c4aae81f-0219-450f-aa60-953964f74172	17
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	214e5a5c-7f3e-478b-93d3-1713de9e7672	9
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	214e5a5c-7f3e-478b-93d3-1713de9e7672	9
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	214e5a5c-7f3e-478b-93d3-1713de9e7672	9
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	8c525e4e-6e1b-4579-e053-2a95a90a43da	6
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	8c525e4e-6e1b-4579-e053-2a95a90a43da	6
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	8c525e4e-6e1b-4579-e053-2a95a90a43da	6
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	e98d11b0-535f-4e57-9639-6358835c04bc	5
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	e98d11b0-535f-4e57-9639-6358835c04bc	5
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	e98d11b0-535f-4e57-9639-6358835c04bc	5
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	8c273efa-62ec-16b2-e053-2995a90ac41d	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	b336f235-5b57-7d6a-e053-2a95a90a0b88	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	88012cf8-509b-84cf-e053-2a95a90af3bc	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	8c273efa-62ec-16b2-e053-2995a90ac41d	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	88012cf8-509b-84cf-e053-2a95a90af3bc	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	b336f235-5b57-7d6a-e053-2a95a90a0b88	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	8c273efa-62ec-16b2-e053-2995a90ac41d	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	b336f235-5b57-7d6a-e053-2a95a90a0b88	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	88012cf8-509b-84cf-e053-2a95a90af3bc	4
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	f309ccbb-b68a-3190-e053-2995a90a0ad4	3
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	f309ccbb-b68a-3190-e053-2995a90a0ad4	3
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	f309ccbb-b68a-3190-e053-2995a90a0ad4	3
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	52ba329a-8cb3-cf30-e063-6394a90aa0dc	1
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	1
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	ea66360f-6ab0-47ff-9b15-37e54395ff2f	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	52ba329a-8cb3-cf30-e063-6394a90aa0dc	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	1
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	ea66360f-6ab0-47ff-9b15-37e54395ff2f	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	52ba329a-8cb3-cf30-e063-6394a90aa0dc	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	1
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	ea66360f-6ab0-47ff-9b15-37e54395ff2f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9803-05	00143980305	500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9803-05)	500 capsule	2010-05-15	0000-00-00	No	No	Current
0143-9803-50	00143980350	50 CAPSULE in 1 BOTTLE, PLASTIC (0143-9803-50)	50 capsule	2010-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Capsules - Hikma	REMEDYREPACK INC.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	26
Doxycycline Hyclate Capsules	Unit Dose Solutions, Inc.	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules - Hikma	PD-Rx Pharmaceuticals, Inc.	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	30
Doxycycline Hyclate Capsules	PD-Rx Pharmaceuticals, Inc.	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	49
Doxycycline Hyclate Capsules - Hikma	Coupler LLC	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules - Hikma	REMEDYREPACK INC.	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	1
Doxycycline Hyclate Capsules - Hikma	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Doxycycline Hyclate Capsules - Hikma	Major Pharmaceuticals	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	17
Doxycycline Hyclate Capsules - Hikma	NuCare Pharmaceuticals,Inc.	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	6
Doxycycline Hyclate Capsules, USP 8451321/0124 Rx only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	5
Doxycycline Hyclate Capsules - Hikma	Hikma Pharmaceuticals USA Inc.	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	50
Doxycycline Hyclate	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules - Hikma	Quality Care Products, LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	11
Doxycycline Hyclate Capsules - Hikma	Bryant Ranch Prepack	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	9
Doxycycline 100MG Hyclate Capsules	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules - Hikma	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	4
Doxycycline Hyclate Capsules - Hikma	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1