Nitrofurantion

Product NDC: 68071-2363
Requested package NDC: 68071-2363-8
11-digit product format: 680712363
Labeler code: 68071
Product ID: 68071-2363_4b353a66-abe4-a233-e063-6294a90a685d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantion
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA201722
Marketing category: ANDA
Marketing start: 2016-04-15
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 7 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
2025-01-11 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201722-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	2016-02-16
A201722-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	2016-02-16
A201722-003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	2016-02-16

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL		2016-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL		2016-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL		2016-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL		2016-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL		2016-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL		2016-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2016-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201722-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2016-02-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201722-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201722-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201722-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201722-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201722-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201722-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201722-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201722-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201722-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201722-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201722-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201722-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201722-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201722-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201722-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201722-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201722-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201722-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201722-001	AB	1	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantion
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
bd46cc46-0efa-d5d9-e053-2995a90a18f1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2363-7	2025-01-10	Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only
68071-2363-8	2025-01-10	Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only
68071-2363-7	2023-01-30	Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only
68071-2363-8	2023-01-30	Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2363-7	Nitrofurantion	14 in 1 BOTTLE	CAPSULE	14		3
68071-2363-8	Nitrofurantion	28 in 1 BOTTLE	CAPSULE	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2363	NITROFURANTION CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250112_bd46cc46-0efa-d5d9-e053-2995a90a18f1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantion	NITROFURANTION	Bryant Ranch Prepack	eeb12928-61ab-42a0-a1fa-2819b9ffa3cb	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722
Nitrofurantion	NITROFURANTION	Sun Pharmaceutical Industries, Inc.	05f25774-f56a-48ef-bac3-8af663f8581a	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722
Nitrofurantion	NITROFURANTION	NuCare Pharmaceuticals,Inc.	bd46cc46-0efa-d5d9-e053-2995a90a18f1	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722 ndc (package): 68071-2363-8 ndc (product): 68071-2363 ndc11 (package): 68071236308
Nitrofurantion	NITROFURANTION	A-S Medication Solutions	43848e61-4d94-46f7-a610-93be927c8d16	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722
Nitrofurantion	NITROFURANTION	Proficient Rx LP	870f64ca-0256-4e3f-8c34-dc603ccc41c0	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722
Nitrofurantion	NITROFURANTION	BluePoint Labortories	ad020393-1c97-49da-b0f3-d6a9359fb73d	2019-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201722 application number: ANDA201722

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	bd46cc46-0efa-d5d9-e053-2995a90a18f1	3
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	bd46cc46-0efa-d5d9-e053-2995a90a18f1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2363-8	68071236308	28 CAPSULE in 1 BOTTLE (68071-2363-8)	28 capsule	2021-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg, 50 mg and 100 mg Rx Only	NuCare Pharmaceuticals,Inc.	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	3