Furadantin

Product NDC: 70199-006
Requested package NDC: 70199-006-32
11-digit product format: 701990006
Labeler code: 70199
Product ID: 70199-006_53b84bd6-6672-4376-8207-84fa5d553e0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Casper Pharma LLC
Application: NDA009175
Marketing category: NDA
Marketing start: 2020-12-23
Marketing end: 0000-00-00
Substance: NITROFURANTOIN
Active strength: 25 mg/5mL
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70199-006	70199-006-32	D	Discontinued by firm		2026-08-03

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
N009175-001	FURADANTIN	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982
N009175-002	FURADANTIN	NITROFURANTOIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009175-001	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 · 62 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
2026-02-19 14:30 UTC	2026-02	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982		`b00525d2431f…`

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	N009175-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009175-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009175-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009175-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009175-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009175-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009175-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009175-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009175-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009175-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009175-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009175-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009175-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009175-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009175-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009175-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009175-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009175-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009175-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009175-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009175-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009175-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009175-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009175-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009175-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009175-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009175-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009175-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009175-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009175-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009175-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009175-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009175-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009175-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009175-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009175-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009175-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009175-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009175-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N009175-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	89095f4d-e142-465e-b378-da24f6eeaf2b	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009175 application number: NDA009175

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70199-006-32	ML - Milliliter	70199-006	c77a7ea0-4cca-4323-b567-9a4f5777f594	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70199-006	FURADANTIN (NITROFURANTOIN) SUSPENSION [CASPER PHARMA LLC]	14	Legacy NDC	20240405_00af0dea-ac7b-43f2-9f51-2a9f9e7f7d21.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70199-006-32	70199000632	1 BOTTLE in 1 CARTON (70199-006-32) > 230 mL in 1 BOTTLE	1 bottle	2020-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Furadantin	Casper Pharma LLC \| APL HEALTHCARE LIMITED	2024-03-28	Human Prescription Drug Label	14