Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC: 70518-0265
Requested package NDC: 70518-0265-2
11-digit product format: 705180265
Labeler code: 70518
Product ID: 70518-0265_4e797ba8-c3db-0bd1-e063-6394a90a4f06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA020064
Marketing category: NDA
Marketing start: 2017-02-28
Substance: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength: 25; 75 mg/1; mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0265	70518-0265-2	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N020064-001	MACROBID	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020064-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020064-001	MACROBID	75MG;25MG	CAPSULE / ORAL	AB	RLD, RS	1991-12-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N020064-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020064-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020064-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020064-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020064-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020064-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020064-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020064-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020064-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020064-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020064-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020064-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020064-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020064-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020064-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020064-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020064-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020064-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020064-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020064-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020064-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020064-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020064-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020064-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020064-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020064-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020064-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020064-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020064-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020064-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020064-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020064-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020064-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020064-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020064-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020064-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020064-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020064-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020064-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020064-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantoin Monohydrate/ Macrocrystalline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	25 mg/1
NITROFURANTOIN MONOHYDRATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
927AH8112L	Internal UNII lookup
E1QI2CQQ1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648755	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
a4afd48b-003f-4ffa-9ca0-9432b8b0e22b	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
70518-0265-0	Nitrofurantoin Monohydrate/ Macrocrystalline	30 in 1 BLISTER PACK	CAPSULE	30	25
70518-0265-1	Nitrofurantoin Monohydrate/ Macrocrystalline	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	25
70518-0265-2	Nitrofurantoin Monohydrate/ Macrocrystalline	14 in 1 BLISTER PACK	CAPSULE	14	25
70518-0265-3	Nitrofurantoin Monohydrate/ Macrocrystalline	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0265	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REMEDYREPACK INC.]	22	Current NDC, Legacy NDC, 4 package rows	20250425_a4afd48b-003f-4ffa-9ca0-9432b8b0e22b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	REMEDYREPACK INC.	a4afd48b-003f-4ffa-9ca0-9432b8b0e22b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064 ndc (package): 70518-0265-2 ndc (product): 70518-0265 ndc11 (package): 70518026502
Macrobid	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	REMEDYREPACK INC.	28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Alvogen Inc.	1a86deef-0887-43b1-bb96-dbc222b15931	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Macrobid	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Almatica Pharma LLC	8f270a9f-12a1-44d4-bc7e-873613555801	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE	NITROFURANTOIN MONOHYDRATE	Direct_Rx	8d2e456a-ffb2-3f1e-e053-2995a90a22df	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Nitrofurantoin Mono	NITROFURANTOIN MONOHYDRATE	PharmPak, Inc.	d9840719-271f-42a9-a5c9-3e039ec8fbac	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064
Nitrofurantoin Monohydrate/ Macrocrystalline	NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE	Proficient Rx LP	22061f76-2c05-4501-b8dd-a5c372abe7c2	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020064 application number: NDA020064

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

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	a4afd48b-003f-4ffa-9ca0-9432b8b0e22b	25
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	a4afd48b-003f-4ffa-9ca0-9432b8b0e22b	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0265-2	70518026502	14 CAPSULE in 1 BLISTER PACK (70518-0265-2)	14 capsule	2019-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)	REMEDYREPACK INC.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	26