Doxycycline Hyclate

Product NDC: 43063-604
Requested package NDC: 43063-604-20
11-digit product format: 430630604
Labeler code: 43063
Product ID: 43063-604_d2b8b725-9731-d707-e053-2a95a90a54d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA062396
Marketing category: ANDA
Marketing start: 1984-05-07
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
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	43063-604	43063-604-20	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
DIACETYLATED MONOGLYCERIDES	INACTIVE INGREDIENT	5Z17386USF	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	24

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-604-20	43063060420	20 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43063-604-20)	2015-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE CAPSULES, USP Rx Only	PD-Rx Pharmaceuticals, Inc.	2021-12-09	HUMAN PRESCRIPTION DRUG LABEL	38