DOXYCYCLINE HYCLATE

Product NDC: 70518-3869
Requested package NDC: 70518-3869-7
11-digit product format: 705183869
Labeler code: 70518
Product ID: 70518-3869_5a6afbf5-95de-515f-e063-6294a90afa9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE HYCLATE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA211343
Marketing category: ANDA
Marketing start: 2023-09-24
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211343-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2019-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211343-001	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 2 · 41 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
2026-09-14 22:38:34	2026-08	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211343-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-10-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A211343-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211343-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211343-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211343-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211343-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211343-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211343-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211343-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211343-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211343-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211343-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211343-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211343-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211343-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211343-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211343-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211343-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211343-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211343-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211343-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211343-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211343-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211343-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211343-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211343-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211343-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211343-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211343-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211343-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211343-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211343-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211343-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211343-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211343-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211343-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211343-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211343-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211343-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211343-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211343-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
5fdc01c3-c62f-40cf-8351-91cbcc43d379	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
70518-3869-0	DOXYCYCLINE HYCLATE	20 in 1 BOTTLE, PLASTIC	TABLET	20	13
70518-3869-1	DOXYCYCLINE HYCLATE	10 in 1 BOTTLE, PLASTIC	TABLET	10	13
70518-3869-2	DOXYCYCLINE HYCLATE	14 in 1 BOTTLE, PLASTIC	TABLET	14	13
70518-3869-3	DOXYCYCLINE HYCLATE	90 in 1 BOTTLE, PLASTIC	TABLET	90	13
70518-3869-4	DOXYCYCLINE HYCLATE	60 in 1 BOTTLE, PLASTIC	TABLET	60	13
70518-3869-5	DOXYCYCLINE HYCLATE	100 in 1 BOTTLE, PLASTIC	TABLET	100	13
70518-3869-6	DOXYCYCLINE HYCLATE	28 in 1 BOTTLE, PLASTIC	TABLET	28	13
70518-3869-7	DOXYCYCLINE HYCLATE	50 in 1 BOTTLE, PLASTIC	TABLET	50	13
70518-3869-8	DOXYCYCLINE HYCLATE	56 in 1 BOTTLE, PLASTIC	TABLET	56	13
70518-3869-9	DOXYCYCLINE HYCLATE	30 in 1 BLISTER PACK	TABLET	30	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3869	DOXYCYCLINE HYCLATE TABLET [REMEDYREPACK INC.]	6	Current NDC, 10 package rows	20250423_5fdc01c3-c62f-40cf-8351-91cbcc43d379.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	5fdc01c3-c62f-40cf-8351-91cbcc43d379	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343 ndc (package): 70518-3869-7 ndc (product): 70518-3869 ndc11 (package): 70518386907
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0106a3d3-db4d-f6ee-e063-6294a90a25e9	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	St. Mary's Medical Park Pharmacy	02f87c60-8425-1a1e-e063-6294a90a0c94	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	7a915c50-6fce-45e6-9554-677bb09a868d	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Cranbury Pharmaceuticals, LLC	fe6985d2-37f7-4277-94a9-f7125b4b3fd7	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Direct_Rx	2ad2b85f-2479-c7cd-e063-6294a90acca1	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	e726157e-ce44-4df3-8161-7016700dd751	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Redpharm Drug	1a3c713f-bc4f-4848-e063-6394a90a0272	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Redpharm Drug	0b251a58-30d8-dfec-e063-6294a90a3b45	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	fd58dbe5-aab2-4378-b054-d5c60d87074e	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Proficient Rx LP	e38f3cd2-47e5-438f-bbe3-50b578360f74	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211343 application number: ANDA211343

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
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	5fdc01c3-c62f-40cf-8351-91cbcc43d379	13
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	5fdc01c3-c62f-40cf-8351-91cbcc43d379	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3869-7	70518386907	50 TABLET in 1 BOTTLE, PLASTIC (70518-3869-7)	50 tablet	2025-07-14	No	No	Current