Doxycycline Hyclate

Product NDC: 46708-482
11-digit product format: 467080482
Labeler code: 46708
Product ID: 46708-482_e1387662-e286-469d-b85f-60344918a17b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA213075
Marketing category: ANDA
Marketing start: 2022-01-04
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213075-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03
A213075-004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213075-001	AB
A213075-002	AB
A213075-003	AB
A213075-004	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 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213075-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-003	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-01-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A213075-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213075-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213075-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213075-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213075-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213075-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213075-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213075-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213075-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213075-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213075-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213075-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213075-004	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
406524	Internal RxNorm lookup
434018	Internal RxNorm lookup
799048	Internal RxNorm lookup
1423080	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
44ac5de1-c0c6-4d58-9a49-b2dae60ea921	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	SPL version
46708-482-31	Doxycycline Hyclate	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	2
46708-482-60	Doxycycline Hyclate	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	2
46708-482-91	Doxycycline Hyclate	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-482	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 3 package rows	20230412_44ac5de1-c0c6-4d58-9a49-b2dae60ea921.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Inc.	3ae4ca12-be39-46b9-bc4c-f8356776c175	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213075 application number: ANDA213075
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Alembic Pharmaceuticals Limited	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2023-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213075 application number: ANDA213075 ndc (product): 46708-482

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
434018	doxycycline hyclate 100 MG Delayed Release Oral Tablet	PSN	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	PSN	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	PSN	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
406524	doxycycline hyclate 75 MG Delayed Release Oral Tablet	PSN	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
434018	doxycycline hyclate 100 MG Delayed Release Oral Tablet	SCD	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
799048	doxycycline hyclate 150 MG Delayed Release Oral Tablet	SCD	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	SCD	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2
406524	doxycycline hyclate 75 MG Delayed Release Oral Tablet	SCD	44ac5de1-c0c6-4d58-9a49-b2dae60ea921	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-482-31	46708048231	100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-31)	2022-01-04	0000-00-00	No	No	Current
46708-482-60	46708048260	60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-60)	2022-01-04	0000-00-00	No	No	Current
46708-482-91	46708048291	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-91)	2022-01-04	0000-00-00	No	No	Current