Nitrofurantoin

Product NDC: 65162-689
11-digit product format: 651620689
Labeler code: 65162
Product ID: 65162-689_96cbbaac-bd28-443c-bc4c-967fa09a2f99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA201679
Marketing category: ANDA
Marketing start: 2011-03-24
Substance: NITROFURANTOIN
Active strength: 25 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201679-001	NITROFURANTOIN	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL			2011-05-11

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 · 42 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
2026-08-18 06:07:40	2026-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL	AB	2011-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201679-001	NITROFURANTOIN	25MG/5ML	SUSPENSION / ORAL		2011-05-11	`e64feba35796…`

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	A201679-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201679-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201679-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201679-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201679-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201679-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201679-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201679-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201679-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201679-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201679-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201679-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201679-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201679-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201679-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201679-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201679-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201679-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201679-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201679-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201679-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201679-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201679-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201679-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201679-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201679-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201679-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201679-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201679-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201679-001	AB	1	`ea1830bbd6c7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201679-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311989	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
11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-689-88	Nitrofurantoin	230 mL in 1 BOTTLE, GLASS	SUSPENSION	230		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-689-88	ML - Milliliter	65162-689	763946ce-49b8-4841-9ad3-f9d2bbc501f9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-689	NITROFURANTOIN SUSPENSION [AMNEAL PHARMACEUTICALS LLC]	16	Current NDC, Legacy NDC, 1 package rows	20241031_11dcea9c-0c62-4153-976b-bd1f8ef1f6d9.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
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals LLC	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201679 application number: ANDA201679 ndc (product): 65162-689
Nitrofurantoin	NITROFURANTOIN	Amneal Pharmaceuticals NY LLC	80129dba-5939-4292-bfd0-8d53ba165941	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201679 application number: ANDA201679

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	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	16
311989	nitrofurantoin 5 MG/ML Oral Suspension	SCD	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	16
311989	nitrofurantoin 25 MG per 5 ML Oral Suspension	SY	11dcea9c-0c62-4153-976b-bd1f8ef1f6d9	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-689-88	65162068988	230 mL in 1 BOTTLE, GLASS (65162-689-88)	230 ml	2011-03-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Oral Suspension USP, 25 mg/5 mL	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	16