Doxycycline Hyclate

Product NDC: 70934-810
Requested package NDC: 70934-810-14
11-digit product format: 709340810
Labeler code: 70934
Product ID: 70934-810_b95acf9c-a784-7548-e053-2a95a90a20d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA062676
Marketing category: ANDA
Marketing start: 2021-01-19
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	70934-810	70934-810-14	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 · 11 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…`

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
A062676-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1986-07-10
A062676-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062676-001	AB
A062676-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`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	A062676-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-810-20	EA - Each	70934-810	e09b8022-52ee-468d-9f74-a78a43927298	1	2022-12-07

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	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	9798c4de-8af7-41c4-acc2-1e9775194297	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	ecab47ea-d7b9-515d-e053-2995a90adc46	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	f5ed9293-15f8-ecfa-e053-2a95a90ab6a4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Quality Care Products, LLC	2a3b79e8-f14c-4b44-9d3e-3c92a82269bd	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-810-14	70934081014	14 CAPSULE in 1 BOTTLE, PLASTIC (70934-810-14)	14 capsule	2021-01-19	0000-00-00	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	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2