Doxycycline Hyclate

Product NDC: 83112-100
Requested package NDC: 83112-100-20
11-digit product format: 831120100
Labeler code: 83112
Product ID: 83112-100_47479ed6-5616-c375-e063-6294a90afef4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Health Department, Oklahoma State
Application: ANDA062269
Marketing category: ANDA
Marketing start: 2025-03-07
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062269-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08
A062269-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062269-002	AB
A062269-003	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 3 · 86 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	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	1982-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		1983-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062269-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1982-11-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062269-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL			1983-10-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A062269-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062269-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062269-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062269-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062269-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062269-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062269-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062269-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062269-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062269-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062269-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062269-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062269-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062269-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062269-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062269-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062269-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062269-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062269-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062269-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062269-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062269-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062269-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062269-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062269-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062269-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062269-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062269-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062269-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline Hyclate
Listing expiration: 2027-12-31

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
1649988	Internal RxNorm lookup
1650143	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
f39365f9-eb64-00cb-e053-2995a90a8d80	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
83112-100-00	Doxycycline Hyclate	14 in 1 PACKET	TABLET, FILM COATED	14	4
83112-100-14	Doxycycline Hyclate	14 in 1 PACKET	TABLET, FILM COATED	14	4
83112-100-20	Doxycycline Hyclate	20 in 1 PACKET	TABLET, FILM COATED	20	4
83112-100-28	Doxycycline Hyclate	28 in 1 PACKET	TABLET, FILM COATED	28	4
83112-100-42	Doxycycline Hyclate	42 in 1 PACKET	TABLET, FILM COATED	42	4
83112-100-56	Doxycycline Hyclate	56 in 1 PACKET	TABLET, FILM COATED	56	4

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	051654c7-8ba6-44f2-842c-72f515e9b32d	2026-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	2305ab4a-7d08-41f6-9c39-c9b6835be389	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Health Department, Oklahoma State	f39365f9-eb64-00cb-e053-2995a90a8d80	2025-12-31	Warnings	Exact identifier application applno (ANDA): 062269 application number: ANDA062269 ndc (package): 83112-100-20 ndc (product): 83112-100 ndc11 (package): 83112010020
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug	44f2fdde-cf84-6f42-e063-6394a90af94e	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	ca63aa91-519d-429f-adfc-a4ec45367294	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
TARGADOX	DOXYCYCLINE HYCLATE	Journey Medical Corporation	83243f78-b984-46a4-a88a-c6a15c217b90	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	JG Pharma Inc.	10b8bf71-4311-41e8-a891-bab8bc86863f	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	61195fc6-3fa7-4203-b526-477b48395856	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	9cbd8699-e2c2-40d4-8797-e676f2a10eb2	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	65cac0b6-3550-48cf-bffa-cf42443c2731	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Epic Pharma, LLC	2b402587-8ecc-4fea-83ad-8071345b6356	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	860a1566-5857-ed88-e053-2991aa0ae2a4	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062269 application number: ANDA062269

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	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	f39365f9-eb64-00cb-e053-2995a90a8d80	4
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	f39365f9-eb64-00cb-e053-2995a90a8d80	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83112-100-20	83112010020	20 TABLET, FILM COATED in 1 PACKET (83112-100-20)	2025-03-07	No	No	Current