nitrofurantoin (macrocrystals)

Product NDC: 59651-795
11-digit product format: 596510795
Labeler code: 59651
Product ID: 59651-795_04053ba5-ceb5-4f34-9878-8abf1e552da2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin (macrocrystals)
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077025
Marketing category: ANDA
Marketing start: 2023-05-17
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A077025-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB		2004-08-18
A077025-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	AB		2024-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077025-001	AB
A077025-002	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 2 · 53 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	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077025-002	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB	2024-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL		2004-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077025-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2004-08-18	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077025-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077025-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077025-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077025-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077025-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077025-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077025-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077025-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077025-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077025-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077025-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077025-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077025-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077025-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077025-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077025-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077025-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077025-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077025-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077025-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077025-001	AB	1	`8072bd15b7f6…`
2019-07-19 19:46 UTC	2019-07	A077025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077025-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077025-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077025-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: nitrofurantoin (macrocrystals)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
927AH8112L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311994	Internal RxNorm lookup
1648759	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b2fc8354-b413-4c9d-88ec-ccc43d059d51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cf	Product name	6	20251106
f6207266-e92b-4b5b-a91b-4af4215c9542	Product name	6	20240813
e31776f7-6119-9577-e170-5b569993276e	Product name	5	20240320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-795-01	nitrofurantoin (macrocrystals)	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-795-01	EA - Each	59651-795	a35f669c-e3cc-4804-a0da-a853a23b9e38	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-795	NITROFURANTOIN (MACROCRYSTALS) CAPSULE [AUROBINDO PHARMA LIMITED]	3	Current NDC, 1 package rows	20241012_b2fc8354-b413-4c9d-88ec-ccc43d059d51.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitrofurantoin (macrocrystals)	NITROFURANTOIN (MACROCRYSTALS)	A-S Medication Solutions	bc90b22e-e48a-4a22-b328-ca5bb2561864	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077025 application number: ANDA077025
nitrofurantoin (macrocrystals)	NITROFURANTOIN (MACROCRYSTALS)	Aurobindo Pharma Limited	b2fc8354-b413-4c9d-88ec-ccc43d059d51	2024-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077025 application number: ANDA077025 ndc (product): 59651-795

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	b2fc8354-b413-4c9d-88ec-ccc43d059d51	3
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	PSN	b2fc8354-b413-4c9d-88ec-ccc43d059d51	3
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	b2fc8354-b413-4c9d-88ec-ccc43d059d51	3
311994	nitrofurantoin, macrocrystals 25 MG Oral Capsule	SCD	b2fc8354-b413-4c9d-88ec-ccc43d059d51	3
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	SY	b2fc8354-b413-4c9d-88ec-ccc43d059d51	3
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	bc90b22e-e48a-4a22-b328-ca5bb2561864	1
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	bc90b22e-e48a-4a22-b328-ca5bb2561864	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59651-795-01	59651079501	100 CAPSULE in 1 BOTTLE (59651-795-01)	100 capsule	2023-05-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Macrocrystals) 100 mg Rx only	A-S Medication Solutions	2024-10-15	Human Prescription Drug Label	1
Nitrofurantoin Capsules, USP (Macrocrystals) 25 mg and 100 mg Rx only	Aurobindo Pharma Limited	2024-10-05	Human Prescription Drug Label	3