Doxycycline

Product NDC: 16714-644
11-digit product format: 167140644
Labeler code: 16714
Product ID: 16714-644_87b32de1-012a-4078-9e90-b036e40da948
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Northstar Rx LLC.
Application: ANDA207757
Marketing category: ANDA
Marketing start: 2022-08-01
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/10mL
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16714-644		D	Discontinued by firm		2026-10-05
excluded package	package	16714-644	16714-644-10	D	Discontinued by firm		2026-10-05

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
A207757-001	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28
A207757-002	DOXYCYCLINE	DOXYCYCLINE HYCLATE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207757-001	AP
A207757-002	AP

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	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2017-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207757-001	DOXYCYCLINE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207757-002	DOXYCYCLINE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2017-09-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A207757-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207757-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207757-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207757-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207757-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207757-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207757-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207757-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207757-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207757-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207757-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207757-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207757-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207757-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207757-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207757-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207757-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207757-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207757-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207757-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207757-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207757-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207757-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207757-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207757-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207757-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207757-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207757-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207757-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207757-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207757-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207757-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207757-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207757-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207757-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207757-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207757-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207757-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207757-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207757-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-644-01	EA - Each	16714-644	c65179ea-d651-4d70-a57d-99ce3df2f4ab	1	2022-09-12
16714-644-10	EA - Each	16714-644	ba677a3b-77d1-475b-a0d5-767ea6e3a06e	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-644	DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC.]	2	Legacy NDC	20241207_7a07694e-490b-4831-8a2c-ac952ef1aa60.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	DOXYCYCLINE	Zydus Pharmaceuticals USA Inc.	7ce80f6e-3c0d-4978-b626-5fd3f3ff349e	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207757 application number: ANDA207757
Doxycycline	DOXYCYCLINE	Zydus Lifesciences Limited	6ae11b4e-1c13-440b-a050-d76e062b0f92	2022-11-05		Exact identifier application applno (ANDA): 207757 application number: ANDA207757

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE
N12000U13O	DOXYCYCLINE	17086-28-1	Doxycycline

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-644-10	16714064410	10 VIAL in 1 CARTON (16714-644-10) > 10 mL in 1 VIAL (16714-644-01)	10 vial	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline for Injection, USP	Northstar Rx LLC. \| Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL	3