Application 080043

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN	TABLET;ORAL	50MG	No	No
002	NITROFURANTOIN	NITROFURANTOIN	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080043-001	NITROFURANTOIN	NITROFURANTOIN	50MG	TABLET / ORAL		Approved before 1982
A080043-002	NITROFURANTOIN	NITROFURANTOIN	100MG	TABLET / ORAL		Approved before 1982

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080043-001	NITROFURANTOIN	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080043-002	NITROFURANTOIN	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`

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 2 · 40 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	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	10e2503d-a250-996f-e063-6294a90abd61	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Preferred Pharmaceuticals Inc.	729f6bbb-ab64-4b65-979a-4ad7605c5947	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	St. Mary's Medical Park Pharmacy	09944470-807d-ad37-e063-6394a90a7bfe	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b6c5bbb0-86db-4a76-a1eb-98573a0b0adc	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	8450fee6-7b9d-4c74-848e-c4f42c1963f9	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Somerset Therapeutics, LLC	dd99ba40-edff-47c3-9ee4-7e5b7774e5b5	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	2a772eb3-4fb3-4d92-b9f4-469dd2216361	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Rising Pharma Holdings, Inc.	89095f4d-e142-465e-b378-da24f6eeaf2b	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	1c5db054-58af-4932-8fad-c3883b13f987	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	d88348a0-6ab4-4490-9325-1f14a541b0a5	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	37606c6f-0d85-4314-94ae-f7732c7bc8d5	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Proficient Rx LP	0819be0b-03e9-426e-a4b9-624c32958f94	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Camber Pharmaceuticals, Inc.	4e06b31e-cc49-4526-beb6-e77021823aa9	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin
Nitrofurantoin	NITROFURANTOIN	Micro Labs Limited	d96098d0-3c2b-4e53-a3f0-3ebba81c4133	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
Nitrofurantoin	NITROFURANTOIN	Redpharm Drug, Inc.	f4c2c01d-bef7-3e5d-e053-2995a90ae0d8	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN generic name: NITROFURANTOIN
NITROFURANTOIN	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Aurobindo Pharma Limited	788f1fe3-d8a1-42cc-9280-07f842da34ea	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-300	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Rebel Distributors Corp	ANDA	Current