nitrofurantoin macrocrystals

Product NDC: 51655-948
11-digit product format: 516550948
Labeler code: 51655
Product ID: 51655-948_49748854-b59f-adc7-e063-6394a90afab7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: NDA016620
Marketing category: NDA
Marketing start: 2023-02-20
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 44.

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	RLD / RS
N016620-001	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	RLD, Approved before 1982
N016620-002	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	RLD, Approved before 1982
N016620-003	MACRODANTIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE / ORAL	RLD, Approved before 1982

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL		RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL		RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL		RLD, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016620-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016620-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016620-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016620-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016620-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016620-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016620-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016620-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016620-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016620-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016620-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016620-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016620-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016620-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016620-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016620-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016620-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016620-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016620-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016620-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016620-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016620-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016620-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016620-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016620-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016620-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016620-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016620-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016620-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016620-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016620-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016620-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016620-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016620-002	AB	1	`b00525d2431f…`

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
f78102eb-cbed-801a-e053-6294a90ab880	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
51655-948-20	nitrofurantoin macrocrystals	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	5
51655-948-29	nitrofurantoin macrocrystals	28 in 1 BOTTLE, PLASTIC	CAPSULE	28	5
51655-948-53	nitrofurantoin macrocrystals	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	5
51655-948-84	nitrofurantoin macrocrystals	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-948	NITROFURANTOIN MACROCRYSTALS CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	4	Current NDC, 4 package rows	20241228_f78102eb-cbed-801a-e053-6294a90ab880.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitrofurantoin macrocrystals	NITROFURANTOIN MACROCRYSTALS	Northwind Health Company, LLC	f78102eb-cbed-801a-e053-6294a90ab880	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016620 application number: NDA016620 ndc (product): 51655-948
Nitrofurantion Macrocrystals	NITROFURANTION MACROCRYSTALS	Proficient Rx LP	3b53f9bf-866a-4cb1-9180-7b13896e26ba	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016620 application number: NDA016620
Nitrofurantion Macrocrystals	NITROFURANTION MACROCRYSTALS	Proficient Rx LP	29b72c21-ab85-41de-b025-f139e6e13ccc	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016620 application number: NDA016620

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	f78102eb-cbed-801a-e053-6294a90ab880	5
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	f78102eb-cbed-801a-e053-6294a90ab880	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-948-20	51655094820	20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20)	20 capsule	2023-02-20	No	No	Current
51655-948-29	51655094829	28 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-29)	28 capsule	2023-02-20	No	No	Current
51655-948-53	51655094853	10 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-53)	10 capsule	2023-08-31	No	No	Current
51655-948-84	51655094884	14 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-84)	14 capsule	2023-05-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (macrocrystals)	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5