Nitrofurantoin

Product NDC: 50090-4591
Requested package NDC: 50090-4591-1
11-digit product format: 500904591
Labeler code: 50090
Product ID: 50090-4591_0a618fb0-ed47-4198-baef-e83e005251aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin monohydrate/macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA207372
Marketing category: ANDA
Marketing start: 2017-05-25
Marketing end: 0000-00-00
Substance: NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength: 75 mg/1; mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC],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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	50090-4591	50090-4591-1	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL			2017-05-15

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	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2017-05-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207372-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207372-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207372-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207372-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207372-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207372-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207372-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207372-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207372-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207372-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207372-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207372-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207372-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207372-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207372-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207372-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207372-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207372-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207372-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207372-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207372-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207372-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207372-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207372-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207372-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207372-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207372-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207372-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207372-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207372-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207372-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207372-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207372-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207372-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207372-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207372-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207372-001	AB	1	`cb3db0bc1861…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4591-1	2023-01-30	C162847	48780-1	f386c64a-288f-0266-e053-dadaa90a7c1a	Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4591-1	Nitrofurantoin(monohydrate/macrocrystals)	10 in 1 BOTTLE	CAPSULE	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4591-1	EA - Each	50090-4591	e3ed0bce-1f56-4870-97f7-e534e4e76fd5	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4591	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 1 package rows	20210803_2bedff75-22c8-49cf-b2e6-8471fd69055c.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 (monohydrate/macrocrystals)	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS	Amneal Pharmaceuticals LLC	55c75f27-b5fc-4f19-8607-08f8ec0c69ec	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207372 application number: ANDA207372

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE	17140-81-7	NITROFURANTOIN MONOHYDRATE
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648755	nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule	PSN	2bedff75-22c8-49cf-b2e6-8471fd69055c	3
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	2bedff75-22c8-49cf-b2e6-8471fd69055c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4591-1	50090459101	10 CAPSULE in 1 BOTTLE (50090-4591-1)	10 capsule	2020-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)	A-S Medication Solutions	2021-08-02	HUMAN PRESCRIPTION DRUG LABEL	3