Application 020064

Type: NDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MACROBID	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	Yes	Yes

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
N020064-001	MACROBID	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020064-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`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	N020064-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020064-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020064-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020064-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020064-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020064-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020064-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020064-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020064-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020064-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020064-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020064-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020064-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020064-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020064-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020064-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020064-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020064-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020064-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020064-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020064-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020064-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020064-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020064-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020064-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020064-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020064-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020064-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020064-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020064-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020064-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020064-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020064-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020064-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020064-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020064-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020064-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020064-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020064-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020064-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	REMEDYREPACK INC.	a4afd48b-003f-4ffa-9ca0-9432b8b0e22b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064 ndc (product): 70518-0265
Macrobid	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	REMEDYREPACK INC.	28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064 ndc (product): 70518-2531
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Alvogen Inc.	1a86deef-0887-43b1-bb96-dbc222b15931	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Macrobid	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Almatica Pharma LLC	8f270a9f-12a1-44d4-bc7e-873613555801	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE	NITROFURANTOIN MONOHYDRATE	Direct_Rx	8d2e456a-ffb2-3f1e-e053-2995a90a22df	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Nitrofurantoin Mono	NITROFURANTOIN MONOHYDRATE	PharmPak, Inc.	d9840719-271f-42a9-a5c9-3e039ec8fbac	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Proficient Rx LP	22061f76-2c05-4501-b8dd-a5c372abe7c2	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 92 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-0265	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	REMEDYREPACK INC.	NDA	Current
70518-2531	Macrobid	Nitrofurantoin Monohydrate/Macrocrystalline	REMEDYREPACK INC.	NDA	Current
70518-2531	Macrobid	Nitrofurantoin Monohydrate/Macrocrystalline	REMEDYREPACK INC.	NDA	Current
70518-2531	Macrobid	Nitrofurantoin Monohydrate/Macrocrystalline	REMEDYREPACK INC.	NDA	Current
70934-047	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-047	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-047	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
71335-0191	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Bryant Ranch Prepack	NDA	Current
71335-0191	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Bryant Ranch Prepack	NDA	Current
71335-0191	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Bryant Ranch Prepack	NDA	Current
76413-113	Macrobid	Nitrofurantoin Monohydrate/Macrocrystalline	Central Texas Community Health Centers	NDA	Current
76413-165	Nitrofurantoin Monohydrate/ Macrocrystalline	Nitrofurantoin Monohydrate/Macrocrystalline	Central Texas Community Health Centers	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73696	SUPPL	2023-03-07
67590	SUPPL	2021-05-25
65961	SUPPL	2021-01-22
21088	SUPPL	2013-09-11
34222	SUPPL	2013-09-09
1962	SUPPL	2011-06-09
34221	SUPPL	2009-03-17
1961	SUPPL	2009-03-06
1960	SUPPL	2007-07-05
34220	SUPPL	2003-11-05
1959	SUPPL	2003-11-05
21087	SUPPL	2003-02-04