Doxycycline Hyclate

Product NDC: 70518-3213
11-digit product format: 705183213
Labeler code: 70518
Product ID: 70518-3213_5217e493-243a-eb31-e063-6394a90a0a2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA062677
Marketing category: ANDA
Marketing start: 2021-09-08
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	70518-3213	70518-3213-0	D	Discontinued by firm	2026-08-10
excluded package	package	70518-3213	70518-3213-2	D	Discontinued by firm	2026-08-10
excluded package	package	70518-3213	70518-3213-3	D	Discontinued by firm	2026-08-10
excluded package	package	70518-3213	70518-3213-5	D	Discontinued by firm	2026-08-10

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 · 4 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-3213-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-3213-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-3213-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-07-10 04:00 UTC · source 2024-07-09	70518-3213-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062677-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062677-001	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
2026-02-19 14:30 UTC	2026-02	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062677-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1986-07-10	`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
2026-02-19 14:30 UTC	2026-02	A062677-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062677-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062677-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062677-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062677-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062677-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062677-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062677-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062677-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062677-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062677-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062677-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062677-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062677-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062677-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062677-001	AB	1	`cb3db0bc1861…`

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c8194d6e-c407-465e-a342-4d2d9756dfc4	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-21	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-03-21	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-03-21	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-03-21	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-03-21	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-01-30	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-01-30	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-01-30	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-01-30	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg
2023-01-30	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3213-0	Doxycycline Hyclate	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	16
70518-3213-1	Doxycycline Hyclate	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	16
70518-3213-2	Doxycycline Hyclate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	16
70518-3213-3	Doxycycline Hyclate	2 in 1 BOX	TABLET, FILM COATED	2	16
70518-3213-4	Doxycycline Hyclate	1 in 1 POUCH	TABLET, FILM COATED	1	16
70518-3213-5	Doxycycline Hyclate	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	16
70518-3213-6	Doxycycline Hyclate	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	16
70518-3213-7	Doxycycline Hyclate	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	16
70518-3213-8	Doxycycline Hyclate	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28	16
70518-3213-9	Doxycycline Hyclate	56 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	56	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3213	DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 10 package rows	20250502_c8194d6e-c407-465e-a342-4d2d9756dfc4.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	c8194d6e-c407-465e-a342-4d2d9756dfc4	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677 ndc (product): 70518-3213
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062677 application number: ANDA062677

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	c8194d6e-c407-465e-a342-4d2d9756dfc4	16
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	c8194d6e-c407-465e-a342-4d2d9756dfc4	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3213-0	70518321300	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-0)	2021-09-08	0000-00-00	No	No	Current
70518-3213-1	70518321301	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-1)	2023-06-25		No	No	Current
70518-3213-2	70518321302	60 in 1 BOTTLE, PLASTIC					Historical
70518-3213-3	70518321303	2 in 1 BOX					Historical
70518-3213-4	70518321304	1 in 1 POUCH					Historical
70518-3213-5	70518321305	20 in 1 BOTTLE, PLASTIC					Historical
70518-3213-6	70518321306	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-6)	2025-04-30		No	No	Current
70518-3213-7	70518321307	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-7)	2026-05-13		No	No	Current
70518-3213-8	70518321308	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-8)	2026-05-13		No	No	Current
70518-3213-9	70518321309	56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3213-9)	2026-05-13		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg	REMEDYREPACK INC.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	17