Application 073652

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A073652-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB		1993-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073652-001	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 2 · 42 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	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A073652-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073652-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073652-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073652-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073652-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073652-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073652-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073652-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073652-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073652-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073652-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073652-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073652-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073652-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073652-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073652-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073652-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073652-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073652-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073652-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073652-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073652-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073652-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073652-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073652-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073652-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073652-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073652-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073652-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073652-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073652-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073652-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073652-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073652-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073652-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073652-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073652-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073652-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073652-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073652-001	AB	1	`e64feba35796…`

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
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	PD-Rx Pharmaceuticals, Inc.	536ed022-db80-492d-b6ab-809855ea90fb	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652 ndc (product): 72789-270
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Amneal Pharmaceuticals of New York LLC	341c75ac-fba5-480d-a221-868c4195cb6f	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652 ndc (product): 0115-1645
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	AvPAK	650f3c60-d45d-4358-a388-7efee4ad0497	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652 ndc (product): 50268-624
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Redpharm Drug	32520c80-0ce5-ea4b-e063-6294a90a37ba	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	c335f76b-6b85-4c9f-bbfa-95514cdd80fa	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652 ndc (product): 71335-1135
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Proficient Rx LP	c87f65b9-14f7-4962-bff6-58b0d1af75f8	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652 ndc (product): 71205-297

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Impax Generics	ANDA	Current
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Impax Generics	ANDA	Current
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1645	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0440-1866	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-601	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Blenheim Pharmacal, Inc.	ANDA	Current
42254-070	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Rebel Distributors Corp	ANDA	Current
50268-624	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	AvPAK	ANDA	Current
50268-624	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	AvPAK	ANDA	Current
50268-624	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	AvPAK	ANDA	Current
50436-6591	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Unit Dose Services	ANDA	Current
60687-316	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	American Health Packaging	ANDA	Current
67296-0658	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	RedPharm Drug Inc.	ANDA	Current
68071-2517	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4644	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4644	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4681	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2602	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	REMEDYREPACK INC.	ANDA	Current
70518-2602	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	REMEDYREPACK INC.	ANDA	Current
70518-2602	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	REMEDYREPACK INC.	ANDA	Current
70934-217	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-217	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-217	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-297	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Proficient Rx LP	ANDA	Current
71205-297	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Proficient Rx LP	ANDA	Current
71205-297	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	Proficient Rx LP	ANDA	Current
71335-1135	Nitrofurantoin	Nitrofurantoin Macrocrystals	Bryant Ranch Prepack	ANDA	Current
71335-1135	Nitrofurantoin	Nitrofurantoin Macrocrystals	Bryant Ranch Prepack	ANDA	Current
72789-270	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-270	Nitrofurantoin Macrocrystals	Nitrofurantoin Macrocrystals	PD-Rx Pharmaceuticals, Inc.	ANDA	Current