Nitrofurantoin

Product NDC: 70518-3717
11-digit product format: 705183717
Labeler code: 70518
Product ID: 70518-3717_4f80c423-d0ae-4468-e063-6294a90a9041
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208516
Marketing category: ANDA
Marketing start: 2023-04-18
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3717	70518-3717-1	D	Discontinued by firm		2026-08-17
excluded package	package	70518-3717	70518-3717-3	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 · 3 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3717	70518-3717-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3717	70518-3717-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3717	70518-3717-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2018-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208516-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`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	A208516-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208516-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208516-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208516-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208516-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208516-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208516-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208516-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208516-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208516-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208516-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208516-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208516-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208516-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208516-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208516-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208516-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208516-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208516-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208516-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208516-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208516-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208516-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208516-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208516-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208516-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208516-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208516-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208516-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208516-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208516-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208516-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208516-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208516-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208516-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208516-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208516-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208516-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208516-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208516-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantoin
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
6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	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
70518-3717-0	Nitrofurantoin	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	9
70518-3717-1	Nitrofurantoin	30 in 1 BLISTER PACK	CAPSULE	30	9
70518-3717-2	Nitrofurantoin	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	9
70518-3717-3	Nitrofurantoin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3717	NITROFURANTOIN CAPSULE [REMEDYREPACK INC.]	6	Current NDC, 4 package rows	20240329_6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5.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	NITROFURANTOIN	NuCare Pharmaceuticals,Inc.	f40af3e1-e54c-3a35-e053-2a95a90a6cb2	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Preferred Pharmaceuticals Inc.	729f6bbb-ab64-4b65-979a-4ad7605c5947	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	St. Mary's Medical Park Pharmacy	09944470-807d-ad37-e063-6394a90a7bfe	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516 ndc (product): 70518-3717
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	1c5db054-58af-4932-8fad-c3883b13f987	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	d88348a0-6ab4-4490-9325-1f14a541b0a5	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	PD-Rx Pharmaceuticals, Inc.	37606c6f-0d85-4314-94ae-f7732c7bc8d5	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Redpharm Drug, Inc.	f4c2c01d-bef7-3e5d-e053-2995a90ae0d8	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	56e07ad3-7224-4aaf-9a68-0d48d4abfec8	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin Monohydrate/Macrocrystal	NITROFURANTOIN MONOHYDRATE/MACROCRYSTAL	Direct_Rx	ee13cf2a-cde0-8ab8-e053-2a95a90a9dda	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	bebbe5d6-f6ec-4191-bad3-b6e933da0688	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	75dab97e-59b4-447c-a8c9-b4d5a970098f	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Bryant Ranch Prepack	b807bd48-71ab-4578-b1d7-4d3260bf6c75	2023-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Trigen Laboratories, LLC	39ffb8c6-4dd8-4436-b857-7306c15f662a	2023-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516
Nitrofurantoin	NITROFURANTOIN	Proficient Rx LP	34d3c103-27b8-454b-9f38-c33157c3b6fc	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208516 application number: ANDA208516

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	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	9
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3717-0	70518371700	14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3717-0)	14 capsule	2023-04-18	No	No	Current
70518-3717-1	70518371701	30 in 1 BLISTER PACK					Historical
70518-3717-2	70518371702	10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3717-2)	10 capsule	2023-09-02	No	No	Current
70518-3717-3	70518371703	20 in 1 BOTTLE, PLASTIC					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals)	REMEDYREPACK INC.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	11