Application 205005

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	50MG	No	No
002	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205005-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	AB		2017-12-12
A205005-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB		2017-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205005-001	AB
A205005-002	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 · 84 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	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A205005-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205005-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205005-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205005-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205005-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205005-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205005-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205005-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205005-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205005-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205005-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205005-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205005-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205005-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205005-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205005-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205005-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205005-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205005-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205005-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205005-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205005-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205005-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205005-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205005-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205005-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205005-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205005-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205005-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205005-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205005-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205005-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205005-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205005-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205005-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205005-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205005-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205005-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205005-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205005-002	AB	1	`bb7c543d1eb4…`

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 macrocrystals	NITROFURANTOIN MACROCRYSTALS	Major Pharmaceuticals	3ee5e79f-1dca-4e1b-95a9-7859bfe344d1	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205005 application number: ANDA205005 ndc (product): 0904-7026
nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	aca04d52-8a64-4fca-94b2-64b46f5a3218	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205005 application number: ANDA205005 ndc (product): 71335-1069
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Zydus Pharmaceuticals (USA) Inc.	2862e49a-66e9-4418-9343-4404036775fc	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205005 application number: ANDA205005 ndc (product): 68382-559 ndc (product): 68382-560
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Zydus Lifesciences Limited	8124bb9f-66af-4251-86b0-d1c247cdcb63	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205005 application number: ANDA205005 ndc (product): 70771-1170 ndc (product): 70771-1171

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7025	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
0904-7025	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
0904-7025	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
0904-7026	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
0904-7026	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
0904-7026	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Major Pharmaceuticals	ANDA	Current
68071-4688	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4688	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-559	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-559	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-559	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-559	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-560	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-560	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-560	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-560	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1170	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1170	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1170	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1170	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1171	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1171	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1171	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
70771-1171	nitrofurantoin macrocrystals	nitrofurantoin macrocrystals	Cadila Healthcare Limited	ANDA	Current
71335-1069	nitrofurantoin	nitrofurantoin macrocrystals	Bryant Ranch Prepack	ANDA	Current
71335-1069	nitrofurantoin	nitrofurantoin macrocrystals	Bryant Ranch Prepack	ANDA	Current