nitrofurantoin macrocrystals

Product NDC: 0904-7026
Requested package NDC: 0904-7026-61
11-digit product format: 009047026
Labeler code: 0904
Product ID: 0904-7026_8d3d6cd5-653a-499e-bc06-78ced2a4d334
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA205005
Marketing category: ANDA
Marketing start: 2018-02-15
Substance: NITROFURANTOIN
Active strength: 50 mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A205005-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205005-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	2017-12-12	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205005-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205005-002	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: nitrofurantoin macrocrystals
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311995	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
3ee5e79f-1dca-4e1b-95a9-7859bfe344d1	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
0904-7026-61	nitrofurantoin macrocrystals	100 in 1 CARTON	CAPSULE	100		7
0904-7026-61	nitrofurantoin macrocrystals	1 in 1 BLISTER PACK	CAPSULE	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7026-61	EA - Each	0904-7026	364cfef4-4ab6-445b-a5f0-6b0eb1754399	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7026	NITROFURANTOIN MACROCRYSTALS CAPSULE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20250330_3ee5e79f-1dca-4e1b-95a9-7859bfe344d1.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 · 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 (package): 0904-7026-61 ndc (product): 0904-7026 ndc11 (package): 00904702661
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
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
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

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
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	PSN	3ee5e79f-1dca-4e1b-95a9-7859bfe344d1	7
311995	nitrofurantoin, macrocrystals 50 MG Oral Capsule	SCD	3ee5e79f-1dca-4e1b-95a9-7859bfe344d1	7
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	SY	3ee5e79f-1dca-4e1b-95a9-7859bfe344d1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7026-61	00904702661	100 BLISTER PACK in 1 CARTON (0904-7026-61) / 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2018-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Macrocrystals) Rx only	Major Pharmaceuticals	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL	7