nitrofurantoin macrocrystals

Product NDC: 47781-308
11-digit product format: 477810308
Labeler code: 47781
Product ID: 47781-308_97785cf3-ab56-4697-3ab6-7451919d889a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Alvogen Inc.
Application: NDA016620
Marketing category: NDA
Marketing start: 2010-09-27
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	47781-308		D	Discontinued by firm		2026-08-17
excluded package	package	47781-308	47781-308-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016620-001	AB
N016620-002	AB
N016620-003	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 4 · 126 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-002	MACRODANTIN	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-003	MACRODANTIN	25MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-001	MACRODANTIN	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N016620-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016620-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016620-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016620-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016620-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016620-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016620-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016620-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016620-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016620-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016620-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016620-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016620-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016620-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016620-001	AB	1	`1e350fbaab3a…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47781-308-01	nitrofurantoin macrocrystals	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-308-01	EA - Each	47781-308	a118f3eb-0804-428a-bbfa-4109079c931d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	8
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTION MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-308	NITROFURANTOIN MACROCRYSTALS CAPSULE [ALVOGEN INC. ]	18	Current NDC, Legacy NDC, 1 package rows	20241018_62c1bb9c-79a2-41e3-9dfa-352f92253881.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
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	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	PSN	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	PSN	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311994	nitrofurantoin, macrocrystals 25 MG Oral Capsule	SCD	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311995	nitrofurantoin, macrocrystals 50 MG Oral Capsule	SCD	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311994	nitrofurantoin macrocrystals 25 MG Oral Capsule	SY	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
311995	nitrofurantoin macrocrystals 50 MG Oral Capsule	SY	62c1bb9c-79a2-41e3-9dfa-352f92253881	19
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	3b53f9bf-866a-4cb1-9180-7b13896e26ba	6
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	3b53f9bf-866a-4cb1-9180-7b13896e26ba	6
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	137b8d13-2e41-4990-8714-4c66c3982be8	5
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
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	137b8d13-2e41-4990-8714-4c66c3982be8	5
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	66474d1d-afc8-f611-e053-2a91aa0acbf5	3
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	66474d1d-afc8-f611-e053-2a91aa0acbf5	3
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	b7581146-886b-4fd3-aa64-2e6dc6832aee	2
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	b7581146-886b-4fd3-aa64-2e6dc6832aee	2
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	3281e6f9-c147-4473-8617-e0ad3352a848	1
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	d4b372d8-88f8-42c2-87ea-61302258c917	1
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	27fa784f-0859-0b97-e054-00144ff8d46c	1
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	3281e6f9-c147-4473-8617-e0ad3352a848	1
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	27fa784f-0859-0b97-e054-00144ff8d46c	1
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	d4b372d8-88f8-42c2-87ea-61302258c917	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-308-01	47781030801	100 CAPSULE in 1 BOTTLE, PLASTIC (47781-308-01)	100 capsule	2010-09-27	0000-00-00	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
Nitrofurantoin Capsules, USP (macrocrystals)	Alvogen Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	19
Nitrofurantoin Capsules, USP (macrocrystals)	REMEDYREPACK INC.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	11
Nitrofurantoin Macrocrystals Capsules	Proficient Rx LP	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	6
Nitrofurantoin Macrocrystals Capsules	PD-Rx Pharmaceuticals, Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	16
NITROFURANTOIN MACROCRYSTALS	DIRECT RX	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
Nitrofurantoin Macrocrystals Capsules	Preferred Pharmaceuticals Inc.	2022-09-14	HUMAN PRESCRIPTION DRUG LABEL	3
Nitrofurantoin Macrocrystals Capsules	Lake Erie Medical DBA Quality Care Products LLC	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Nitrofurantoin Macrocrystals Capsules	Major Pharmaceuticals	2021-10-21	HUMAN PRESCRIPTION DRUG LABEL	1
Nitrofurantoin Macrocrystals Capsules	NuCare Pharmaceuticals, Inc.	2020-01-30	HUMAN PRESCRIPTION DRUG LABEL	2
Nitrofurantoin Macrocrystals Capsules	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
Nitrofurantoin Macrocrystals Capsules	A-S Medication Solutions	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	5
Nitrofurantoin Macrocrystals Capsules	Unit Dose Services	2018-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
Nitrofurantoin Macrocrystals Capsules	Central Texas Community Health Centers	2017-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Nitrofurantoin Macrocrystals Capsules	Bryant Ranch Prepack	2017-06-19	HUMAN PRESCRIPTION DRUG LABEL	2
Nitrofurantoin Macrocrystals Capsules	Apotheca Inc.	2015-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
Nitrofurantoin Macrocrystals Capsules	Aidarex Pharmaceuticals LLC	2014-01-18	HUMAN PRESCRIPTION DRUG LABEL	1