DOXYCYCLINE

Product NDC: 72266-237
11-digit product format: 722660237
Labeler code: 72266
Product ID: 72266-237_31ba285b-5aef-ff76-e063-6294a90a9321
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: FOSUN PHARMA USA INC
Application: ANDA215583
Marketing category: ANDA
Marketing start: 2023-04-12
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/10mL
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A215583-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP		2023-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215583-001	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.

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	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215583-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	AP	2023-04-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215583-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215583-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215583-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215583-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215583-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215583-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215583-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215583-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215583-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215583-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215583-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215583-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215583-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215583-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215583-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215583-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215583-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215583-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215583-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215583-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215583-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215583-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215583-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: DOXYCYCLINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/10mL

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
310027	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
fa3fbb09-b830-60c5-e053-6394a90a4165	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	Strength	SPL version
72266-237-01	DOXYCYCLINE	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10		6
72266-237-05	DOXYCYCLINE	5 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-237-01	EA - Each	72266-237	4e56dc5a-99eb-4ea7-a739-b9786aac8631	1	2023-07-06
72266-237-05	EA - Each	72266-237	8a20933a-e1b8-489e-beba-2f3c2bfbc122	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72266-237	DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]	5	Current NDC, 2 package rows	20250327_fa3fbb09-b830-60c5-e053-6394a90a4165.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXYCYCLINE	DOXYCYCLINE	JVET PHARMACEUTICALS LLC	ed95709e-2a1a-4deb-88bd-5b99f02b7a26	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215583 application number: ANDA215583
DOXYCYCLINE	DOXYCYCLINE	Piramal Critical Care Inc	fd672959-014f-8300-e053-6394a90a5ec5	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215583 application number: ANDA215583
DOXYCYCLINE	DOXYCYCLINE	FOSUN PHARMA USA INC	fa3fbb09-b830-60c5-e053-6394a90a4165	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215583 application number: ANDA215583 ndc (product): 72266-237
DOXYCYCLINE	DOXYCYCLINE	Gland Pharma Limited	6a5780a9-4548-427c-972a-ef49fdcbc84d	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215583 application number: ANDA215583

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310027	doxycycline hyclate 100 MG Injection	PSN	fa3fbb09-b830-60c5-e053-6394a90a4165	6
310027	doxycycline hyclate 100 MG Injection	SCD	fa3fbb09-b830-60c5-e053-6394a90a4165	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72266-237-01	72266023701	10 mL in 1 VIAL	10 ml				Historical
72266-237-05	72266023705	5 VIAL in 1 CARTON (72266-237-05) / 10 mL in 1 VIAL (72266-237-01)	5 vial	2023-04-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE	FOSUN PHARMA USA INC \| Gland Pharma Limited	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	6