nitrofurantoin macrocrystals

Product NDC: 82804-131
Requested package NDC: 82804-131-20
11-digit product format: 828040131
Labeler code: 82804
Product ID: 82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA217272
Marketing category: ANDA
Marketing start: 2023-03-21
Substance: NITROFURANTOIN
Active strength: 100 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217272-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	AB		2023-03-21
A217272-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	AB		2023-03-21
A217272-003	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB	RS	2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217272-001	AB
A217272-002	AB
A217272-003	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 · 75 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
2026-09-14 22:38:34	2026-08	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	RS	2023-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-002	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB		2023-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-003	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB		2023-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217272-001	NITROFURANTOIN	25MG	CAPSULE / ORAL	AB		2023-03-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A217272-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217272-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217272-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217272-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217272-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217272-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217272-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217272-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217272-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217272-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217272-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217272-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217272-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217272-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217272-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217272-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217272-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217272-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217272-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217272-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217272-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217272-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217272-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217272-001	AB	1	`301d65b070ca…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ef7053f3-3081-49c4-9c78-d40a01177fd9	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	SPL version
82804-131-14	nitrofurantoin macrocrystals	14 in 1 BOTTLE	CAPSULE	14	3
82804-131-20	nitrofurantoin macrocrystals	20 in 1 BOTTLE	CAPSULE	20	3
82804-131-28	nitrofurantoin macrocrystals	28 in 1 BOTTLE	CAPSULE	28	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-131-14	EA - Each	82804-131	012ce102-e233-4fea-9c1f-ab8250bab171	1	2024-12-10
82804-131-20	EA - Each	82804-131	00dc8e36-41a7-432b-9442-ca15fbbf9122	1	2024-08-12
82804-131-28	EA - Each	82804-131	971b802c-2c9b-4405-bdaa-20190880074c	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-131	NITROFURANTOIN MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	3	Current NDC, 3 package rows	20240822_ef7053f3-3081-49c4-9c78-d40a01177fd9.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	BluePoint Laboratories	cfa20cfd-478f-48c6-9b59-3c425abd766a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	REMEDYREPACK INC.	27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a1	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Direct_Rx	10d05283-e247-4e60-e063-6294a90ac292	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Northwind Health Company, LLC	075fe819-fc4f-2dce-e063-6294a90ad823	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	VERITYRX, LLC	42a1c744-93dc-31cc-e063-6294a90ab912	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	PD-Rx Pharmaceuticals, Inc.	f28d72be-56d7-467f-a3f8-9ffd57d0dffa	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Proficient Rx LP	ef7053f3-3081-49c4-9c78-d40a01177fd9	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272 ndc (package): 82804-131-20 ndc (product): 82804-131 ndc11 (package): 82804013120
nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	A-S Medication Solutions	4cd9e234-a2b9-4201-b8f8-cf37c0672de7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	American Health Packaging	ce4afef1-22c1-4a1c-a102-a32fb6a2e045	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	NorthStar RxLLC	1e3c284a-539d-4923-a5f6-547390baf811	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	af291b9c-d1b4-42c3-a1e9-bdf3b63fd7e6	2023-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	4bac93c7-dd35-4f5a-8067-5c6fcccc729d	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Lifestar Pharma LLC	6ec66cc8-938f-4839-98c7-a51c9f1d50ed	2023-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217272 application number: ANDA217272

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	ef7053f3-3081-49c4-9c78-d40a01177fd9	3
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	ef7053f3-3081-49c4-9c78-d40a01177fd9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-131-20	82804013120	20 CAPSULE in 1 BOTTLE (82804-131-20)	20 capsule	2024-07-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Macrocrystals) Rx only	Proficient Rx LP	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	3