Nitrofurantoin

Product NDC: 16571-888
11-digit product format: 165710888
Labeler code: 16571
Product ID: 16571-888_b6694787-d7b8-4bcb-8dff-5ff30a83443a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: NDA009175
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-02-01
Substance: NITROFURANTOIN
Active strength: 50 mg/5mL
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [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 42.

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 · 64 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
2026-08-18 06:07:40	2026-07	N009175-001	FURADANTIN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009175-002	FURADANTIN	50MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-06-09	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N009175-001	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
927AH8112L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311989	Internal RxNorm lookup
422434	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
89095f4d-e142-465e-b378-da24f6eeaf2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cf	Product name	6	20251106
f6207266-e92b-4b5b-a91b-4af4215c9542	Product name	6	20240813
e31776f7-6119-9577-e170-5b569993276e	Product name	5	20240320
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16571-888-06	Nitrofurantoin	60 mL in 1 BOTTLE	SUSPENSION	60		5
16571-888-06	Nitrofurantoin	1 in 1 CARTON	SUSPENSION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-888-06	ML - Milliliter	16571-888	c8acd593-6b04-4db5-a93c-0108f577d9e1	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-888	NITROFURANTOIN SUSPENSION [RISING PHARMA HOLDINGS, INC.]	4	Current NDC, 2 package rows	20240406_89095f4d-e142-465e-b378-da24f6eeaf2b.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 · 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 ndc (product): 16571-888

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311989	nitrofurantoin 25 MG in 5 mL Oral Suspension	PSN	89095f4d-e142-465e-b378-da24f6eeaf2b	5
422434	nitrofurantoin 50 MG in 5 mL Oral Suspension	PSN	89095f4d-e142-465e-b378-da24f6eeaf2b	5
422434	nitrofurantoin 10 MG/ML Oral Suspension	SCD	89095f4d-e142-465e-b378-da24f6eeaf2b	5
311989	nitrofurantoin 5 MG/ML Oral Suspension	SCD	89095f4d-e142-465e-b378-da24f6eeaf2b	5
311989	nitrofurantoin 25 MG per 5 ML Oral Suspension	SY	89095f4d-e142-465e-b378-da24f6eeaf2b	5
422434	nitrofurantoin 50 MG per 5 ML Oral Suspension	SY	89095f4d-e142-465e-b378-da24f6eeaf2b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16571-888-06	16571088806	1 BOTTLE in 1 CARTON (16571-888-06) / 60 mL in 1 BOTTLE	1 bottle	2024-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin	Rising Pharma Holdings, Inc. \| APL HEALTHCARE LIMITED	2025-11-11	Human Prescription Drug Label	5