NITROFURANTOIN

Product NDC: 46708-391
Requested package NDC: 46708-391-91
11-digit product format: 467080391
Labeler code: 46708
Product ID: 46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NITROFURANTOIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA211935
Marketing category: ANDA
Marketing start: 2021-07-01
Substance: NITROFURANTOIN
Active strength: 100 mg/1
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 43.

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	TE codes	Approval date
A211935-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	AB	2021-06-25
A211935-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	AB	2021-06-25
A211935-003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB	2021-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211935-001	AB
A211935-002	AB
A211935-003	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 3 · 105 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	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2021-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2021-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211935-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2021-06-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211935-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211935-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211935-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211935-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211935-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211935-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211935-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211935-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211935-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211935-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211935-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211935-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211935-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211935-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211935-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211935-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211935-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211935-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211935-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211935-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211935-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211935-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211935-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211935-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	100 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311994	Internal RxNorm lookup
311995	Internal RxNorm lookup
1648759	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
152e4fe2-7665-4725-af76-b241bd816937	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
46708-391-31	2023-02-01	Nitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-91	2023-02-01	Nitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-31	2023-01-30	Nitrofurantoin Capsules, USP (Macrocrystals) Rx Only
46708-391-91	2023-01-30	Nitrofurantoin Capsules, USP (Macrocrystals) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-391-31	NITROFURANTOIN	100 in 1 BOTTLE	CAPSULE	100		2
46708-391-91	NITROFURANTOIN	1000 in 1 BOTTLE	CAPSULE	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-391	NITROFURANTOIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20230202_152e4fe2-7665-4725-af76-b241bd816937.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROFURANTOIN	NITROFURANTOIN	REMEDYREPACK INC.	87505f8f-2056-4e55-adf5-5b7309081d7c	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211935 application number: ANDA211935
NITROFURANTOIN	NITROFURANTOIN	Proficient Rx LP	0819be0b-03e9-426e-a4b9-624c32958f94	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211935 application number: ANDA211935
NITROFURANTOIN	NITROFURANTOIN	Alembic Pharmaceuticals Inc.	a8a0d7d7-1e18-46a7-a1f8-e97499820035	2023-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211935 application number: ANDA211935
NITROFURANTOIN	NITROFURANTOIN	Alembic Pharmaceuticals Limited	152e4fe2-7665-4725-af76-b241bd816937	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211935 application number: ANDA211935 ndc (package): 46708-391-91 ndc (product): 46708-391 ndc11 (package): 46708039191

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	152e4fe2-7665-4725-af76-b241bd816937	2
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	PSN	152e4fe2-7665-4725-af76-b241bd816937	2
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	PSN	152e4fe2-7665-4725-af76-b241bd816937	2
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	152e4fe2-7665-4725-af76-b241bd816937	2
311994	nitrofurantoin, macrocrystals 25 MG Oral Capsule	SCD	152e4fe2-7665-4725-af76-b241bd816937	2
311995	nitrofurantoin, macrocrystals 50 MG Oral Capsule	SCD	152e4fe2-7665-4725-af76-b241bd816937	2
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	SY	152e4fe2-7665-4725-af76-b241bd816937	2
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	SY	152e4fe2-7665-4725-af76-b241bd816937	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-391-91	46708039191	1000 CAPSULE in 1 BOTTLE (46708-391-91)	1000 capsule	2021-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Macrocrystals) Rx Only	Alembic Pharmaceuticals Limited	2023-01-30	Human Prescription Drug Label	2