Nitrofurantoin

Product NDC: 0115-2024
11-digit product format: 001152024
Labeler code: 0115
Product ID: 0115-2024_02cea479-7d68-4d65-9d78-9529e02453c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA091095
Marketing category: ANDA
Marketing start: 2015-10-01
Marketing end: 0000-00-00
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0115-2024		I	Inactivated by FDA		2026-08-17
excluded package	package	0115-2024	0115-2024-10	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-2024-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-2024-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-2024-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-2024-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-2024-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-2024-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-2024-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-2024-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-2024-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-2024-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-2024-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-2024-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-2024-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-2024-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-2024-10	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091095-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	2015-06-18
A091095-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	2015-06-18
A091095-003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	2015-06-18

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091095-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	2015-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091095-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	2015-06-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091095-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091095-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091095-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091095-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091095-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091095-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091095-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091095-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091095-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091095-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091095-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091095-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091095-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091095-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091095-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091095-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091095-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091095-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091095-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091095-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091095-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091095-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091095-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091095-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091095-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091095-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091095-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091095-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091095-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091095-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091095-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091095-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091095-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091095-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091095-003	AB	1	`ea99ee380514…`
2024-02-18 07:12 UTC	2024-02	A091095-001	AB	1	`1c564ffb4f44…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-2024-10	2023-01-30	C162847	48780-1	f386c649-a42e-0266-e053-dadaa90a7c1a	Nitrofurantoin Capsules USP (Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-2024-10	Nitrofurantoin	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-2024	NITROFURANTOIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	2	Legacy NDC, 1 package rows	20201022_acd6608c-66de-4f17-9fd1-d408e388b764.zip

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
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	acd6608c-66de-4f17-9fd1-d408e388b764	2
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	PSN	acd6608c-66de-4f17-9fd1-d408e388b764	2
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	acd6608c-66de-4f17-9fd1-d408e388b764	2
311995	nitrofurantoin, macrocrystals 50 MG Oral Capsule	SCD	acd6608c-66de-4f17-9fd1-d408e388b764	2
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	SY	acd6608c-66de-4f17-9fd1-d408e388b764	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-2024-10	00115202410	100 CAPSULE in 1 BOTTLE (0115-2024-10)	100 capsule	2015-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules USP (Macrocrystals)	Amneal Pharmaceuticals of New York LLC	2020-10-21	HUMAN PRESCRIPTION DRUG LABEL	2