Nitrofurantoin Macrocrystals

Product NDC: 70518-2602
Requested package NDC: 70518-2602-0
11-digit product format: 705182602
Labeler code: 70518
Product ID: 70518-2602_d6aab86a-e4ee-59b4-e053-2995a90a2b90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA073652
Marketing category: ANDA
Marketing start: 2020-02-26
Marketing end: 0000-00-00
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
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	70518-2602	70518-2602-0	D	Discontinued by firm		2026-09-14

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 · 11 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A073652-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB		1993-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073652-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A073652-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073652-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073652-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073652-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073652-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073652-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073652-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073652-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073652-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073652-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073652-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073652-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073652-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073652-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073652-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073652-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073652-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073652-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073652-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073652-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073652-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073652-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073652-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073652-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073652-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073652-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073652-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073652-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073652-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073652-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073652-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073652-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073652-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073652-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073652-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073652-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073652-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073652-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073652-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073652-001	AB	1	`f41ea6bd6efb…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2602-0	2022-01-30	C162847	48780-1	d6a99b39-e39f-a426-e053-dadaa90af4c2	NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
70518-2602-0	2022-01-28	C162847	48780-1	d6a99b39-e39f-a426-e053-dadaa90af4c2	NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	PD-Rx Pharmaceuticals, Inc.	536ed022-db80-492d-b6ab-809855ea90fb	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Amneal Pharmaceuticals of New York LLC	341c75ac-fba5-480d-a221-868c4195cb6f	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	AvPAK	650f3c60-d45d-4358-a388-7efee4ad0497	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Redpharm Drug	32520c80-0ce5-ea4b-e063-6294a90a37ba	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin	NITROFURANTOIN MACROCRYSTALS	Bryant Ranch Prepack	c335f76b-6b85-4c9f-bbfa-95514cdd80fa	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	Proficient Rx LP	c87f65b9-14f7-4962-bff6-58b0d1af75f8	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073652 application number: ANDA073652

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2602-0	70518260200	14 CAPSULE in 1 BOTTLE, PLASTIC (70518-2602-0)	14 capsule	2020-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only	REMEDYREPACK INC.	2024-09-13	HUMAN PRESCRIPTION DRUG LABEL	8