Furosemide

Product NDC: 83634-302
11-digit product format: 836340302
Labeler code: 83634
Product ID: 83634-302_1b3f2803-b618-4447-b5ac-cd2bdc7de3e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: furosemide
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Avenacy Inc.
Application: ANDA203428
Marketing category: ANDA
Marketing start: 2024-03-15
Substance: FUROSEMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
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
A203428-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP		2014-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203428-001	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.

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	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`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	A203428-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203428-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203428-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203428-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203428-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203428-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203428-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203428-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203428-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203428-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203428-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203428-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203428-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203428-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203428-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203428-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203428-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203428-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203428-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203428-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203428-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203428-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203428-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203428-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203428-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203428-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203428-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203428-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203428-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203428-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203428-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203428-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203428-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203428-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203428-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203428-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203428-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203428-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203428-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203428-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FUROSEMIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7LXU5N7ZO5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1719286	Internal RxNorm lookup
1719290	Internal RxNorm lookup
1719291	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
7d0db0f7-bf4f-4b0b-9359-2a838626e04b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d80d3aff-3a63-4d7b-a2be-fd9388b04330	Product name	9	20250806
9061e89f-9c86-4196-b34b-886fc1673cc4	Product name	1	20140821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83634-302-02	Furosemide	25 in 1 CARTON	INJECTION, SOLUTION	25	4
83634-302-04	Furosemide	25 in 1 CARTON	INJECTION, SOLUTION	25	4
83634-302-10	Furosemide	25 in 1 CARTON	INJECTION, SOLUTION	25	4
83634-302-41	Furosemide	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	4
83634-302-42	Furosemide	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	4
83634-302-43	Furosemide	4 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	4	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83634-302-02	ML - Milliliter	83634-302	91284df3-978c-4c32-bc66-9e5a7199c6a4	1	2024-10-04
83634-302-04	ML - Milliliter	83634-302	d321b5b3-a118-4cf8-8688-f320354359d8	1	2024-10-04
83634-302-10	ML - Milliliter	83634-302	17cddaa5-e844-45da-a178-abe0a2c1f4ba	1	2024-04-05
83634-302-41	ML - Milliliter	83634-302	53a5c70a-8255-42d8-894e-462f9770a8bd	1	2025-03-04
83634-302-42	ML - Milliliter	83634-302	701c5cca-69cd-4ee8-946e-006add8e0c35	1	2024-10-04
83634-302-43	ML - Milliliter	83634-302	2144e448-d00d-4d7e-b1f7-8650a7f25ed5	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83634-302	FUROSEMIDE INJECTION, SOLUTION [AVENACY INC.]	4	Current NDC, 6 package rows	20250416_7d0db0f7-bf4f-4b0b-9359-2a838626e04b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	ProPharma Distribution	38550de1-f099-0cdf-e063-6294a90a9e26	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	ProPharma Distribution	43053bf7-9050-dba8-e063-6294a90a7174	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	NorthStar Rx LLC	fc3194a3-7e75-4551-8334-4a5cc22d9f8b	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Maiva Pharma Private Limited	e5880bf4-5037-4813-b7cc-656a6832ecb5	2025-06-13	Warnings	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Avenacy Inc.	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428 ndc (product): 83634-302
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0aab9759-ee48-d1d3-e063-6394a90a2741	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0a105e0b-b5cc-d929-e063-6294a90a80af	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	ea4ead7c-c798-2d85-e053-2a95a90ab0b0	2023-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7LXU5N7ZO5	FUROSEMIDE	54-31-9	FUROSEMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719286	furosemide 100 MG in 10 ML Injection	PSN	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719290	furosemide 20 MG in 2 ML Injection	PSN	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719291	furosemide 40 MG in 4 ML Injection	PSN	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719286	10 ML furosemide 10 MG/ML Injection	SCD	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719290	2 ML furosemide 10 MG/ML Injection	SCD	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719291	4 ML furosemide 10 MG/ML Injection	SCD	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719286	furosemide 100 MG per 10 ML Injection	SY	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719290	furosemide 20 MG per 2 ML Injection	SY	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4
1719291	furosemide 40 MG per 4 ML Injection	SY	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83634-302-02	83634030202	25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-302-42)		2024-03-15	No	No	Current
83634-302-04	83634030204	25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-302-43)		2024-03-15	No	No	Current
83634-302-10	83634030210	25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-302-41)		2024-03-15	No	No	Current
83634-302-41	83634030241	10 mL in 1 VIAL, SINGLE-DOSE	10 ml				Historical
83634-302-42	83634030242	2 mL in 1 VIAL, SINGLE-DOSE	2 ml				Historical
83634-302-43	83634030243	4 mL in 1 VIAL, SINGLE-DOSE	4 ml				Historical