Application 076951

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL			2005-03-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076951-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	2005-03-30	`cb3db0bc1861…`

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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	BluePoint Laboratories	ea28d766-d6e6-43d2-8282-dc78a0381057	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	513b514f-6e79-f187-e063-6394a90a07dc	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	5087f071-5ef4-753e-e063-6294a90afb8d	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	e55f3dc2-c754-4550-a2c0-c304471a8791	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Creekwood Pharmaceuticals LLC	e47175a3-68a2-4084-9c0e-96fb057448bf	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Major Pharmaceuticals	85c7d4ee-99f5-4324-a5fa-601c2fe664ab	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Redpharm Drug	18987b15-6554-6b55-e063-6294a90a58d4	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	25172572-dbdc-db70-e063-6394a90aa87b	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Preferred Pharmaceuticals Inc.	11e8f91c-5712-4267-9956-e619d081d1f4	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	155c8d68-576e-f85c-e063-6294a90ada4b	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Redpharm Drug	3dd034a6-8810-93f5-e063-6394a90a36c2	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	055477be-e42c-fe8b-e063-6394a90a0449	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)
NITROFURANTOIN (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Jubilant Cadista Pharmaceuticals Inc.	1f7a9414-5592-f2ca-e063-6394a90a75f4	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: NITROFURANTOIN (monohydrate/macrocrystals)

Application 076951

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#