Nitrofurantoin

Product NDC: 68071-2928
11-digit product format: 680712928
Labeler code: 68071
Product ID: 68071-2928_5c194601-e752-5395-e063-6394a90abc4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA208516
Marketing category: ANDA
Marketing start: 2018-01-01
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

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2928-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2928-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2928-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2928-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2928-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2928-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2928-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2928-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2928-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2928-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2928-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2928-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2928-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2928-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2928-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2928-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2928-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2928-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	A208516-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2018-05-24	`84e616aacf4f…`
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…`

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	A208516-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68071-2928-4	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-2928-4	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-2928-4	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-2928-6	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-2928-6	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-2928-6	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2928-4	Nitrofurantoin	14 in 1 BOTTLE	CAPSULE	14		3
68071-2928-6	Nitrofurantoin	6 in 1 BOTTLE	CAPSULE	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2928	NITROFURANTOIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, 2 package rows	20231021_f40af3e1-e54c-3a35-e053-2a95a90a6cb2.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin	NITROFURANTOIN	REMEDYREPACK INC.	6c82b95d-2c32-4e54-a8a9-a4bb4df70cb5	2026-08-19	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	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	f40af3e1-e54c-3a35-e053-2a95a90a6cb2	3
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	f40af3e1-e54c-3a35-e053-2a95a90a6cb2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-2928-1	68071292801	10 CAPSULE in 1 BOTTLE (68071-2928-1)	10 capsule	2023-02-06	No	No	Current
68071-2928-2	68071292802	20 CAPSULE in 1 BOTTLE (68071-2928-2)	20 capsule	2023-02-06	No	No	Current
68071-2928-4	68071292804	14 CAPSULE in 1 BOTTLE (68071-2928-4)	14 capsule	2023-02-06	No	No	Current
68071-2928-6	68071292806	6 CAPSULE in 1 BOTTLE (68071-2928-6)	6 capsule	2023-02-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)	NuCare Pharmaceuticals,Inc.	2026-09-22	HUMAN PRESCRIPTION DRUG LABEL	5