Nitrofurantoin

Product NDC: 71335-0863
Requested package NDC: 71335-0863-9
11-digit product format: 713350863
Labeler code: 71335
Product ID: 71335-0863_443d502c-58be-4421-8904-ffe59c4d1aba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin monohydrate/macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207372
Marketing category: ANDA
Marketing start: 2017-05-25
Marketing end: 0000-00-00
Substance: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	71335-0863	71335-0863-9	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A207372-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL		2017-05-15	`84e616aacf4f…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0863-1	EA - Each	71335-0863	29f6edd8-f1a4-4b01-84a5-86b66daa1fda	1	2020-09-14
71335-0863-2	EA - Each	71335-0863	6ff313c8-67e4-4dc7-ae8d-0caedd6f9614	1	2020-09-14
71335-0863-3	EA - Each	71335-0863	e06b70f8-2b43-4a5e-96d2-3f1fe1ea6822	1	2020-09-14
71335-0863-6	EA - Each	71335-0863	9eb607d9-7c52-4beb-8af2-74029ac9e235	1	2020-09-14
71335-0863-7	EA - Each	71335-0863	bfa29499-e33a-458a-a720-8837b501b9e8	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0863	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK]	10	Legacy NDC	20231110_443d502c-58be-4421-8904-ffe59c4d1aba.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
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN
E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE	17140-81-7	NITROFURANTOIN MONOHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0863-9	71335086309	8 CAPSULE in 1 BOTTLE (71335-0863-9)	8 capsule	2021-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)	Bryant Ranch Prepack	2023-11-09	HUMAN PRESCRIPTION DRUG LABEL	10