Nitrofurantoin (monohydrate/macrocrystals)

Product NDC: 16714-439
Requested package NDC: 16714-439-02
11-digit product format: 167140439
Labeler code: 16714
Product ID: 16714-439_353af088-0bfd-4f93-8923-54a5be3b0aa9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin (monohydrate/macrocrystals)
Dosage form: CAPSULE
Route: ORAL
Labeler: Northstar RxLLC
Application: ANDA077066
Marketing category: ANDA
Marketing start: 2014-11-01
Marketing end: 0000-00-00
Substance: NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength: 75 mg/1; mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-439	16714-439-02	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-439	16714-439-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2005-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077066-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077066-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-439-01	EA - Each	16714-439	c9b2ea9b-80a9-45fa-a51e-8fe1484c4f7b	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
NITROFURANTOIN MONOHYDRATE	ACTIVE INGREDIENT	E1QI2CQQ1I	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-439	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHSTAR RXLLC]	17	Legacy NDC	20240320_d0dbfce6-d5ea-41d8-b568-c021bc77457b.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	68a651f9-1aef-792e-e053-2991aa0a3cbb	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	6bccbaab-151b-4a04-e053-2991aa0ae105	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Sandoz Inc	7ba9a729-a73a-4a13-a336-0284cc8a67e1	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	05f4b126-0fb9-5ee9-c89c-f229e60f84e3	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	1ab658f0-021a-46a1-bff3-d3334c23442d	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	d802d734-dc8f-4f3c-bce6-aaccc4614c89	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE	17140-81-7	NITROFURANTOIN MONOHYDRATE
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648755	nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule	PSN	b644426c-c8ba-4fe0-80c7-d9b2dde37395	3
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	b644426c-c8ba-4fe0-80c7-d9b2dde37395	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-439-02	16714043902	1000 CAPSULE in 1 BOTTLE (16714-439-02)	1000 capsule	2014-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)	A-S Medication Solutions	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	3
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	18
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)	A-S Medication Solutions	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	1
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (Twice-a-day Dosage)	Northstar RxLLC	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	17