Nitrofurantoin Macrocrystals

Product NDC: 67296-0658
11-digit product format: 672960658
Labeler code: 67296
Product ID: 67296-0658_fda7b707-6391-403d-afd8-f825dc76777c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug Inc.
Application: ANDA073652
Marketing category: ANDA
Marketing start: 2011-01-10
Marketing end: 0000-00-00
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-0658		I	Inactivated by FDA		2026-10-05
excluded package	package	67296-0658	67296-0658-1	I	Inactivated by FDA		2026-10-05

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 · 44 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	67296-0658-1	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	67296-0658-1	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	67296-0658-1	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	67296-0658-1	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	67296-0658-1	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	67296-0658-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-0658-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-0658-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-0658-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-0658-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-0658-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0658-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0658-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0658-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0658-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67296-0658-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67296-0658-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67296-0658-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67296-0658-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67296-0658-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67296-0658-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-0658-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

Reported adverse events (FAERS/openFDA)#

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

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0658-1	2020-01-31	C162847	48780-1	9d75b9d0-cdcf-f424-e053-dadaa90a57ce	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0658-1	Nitrofurantoin Macrocrystals	14 in 1 BOTTLE	CAPSULE	14		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0658	NITROFURANTOIN MACROCRYSTALS CAPSULE [REDPHARM DRUG INC.]	1	Legacy NDC, 1 package rows	20110623_dc6bc96c-9a40-469a-9b7c-9cb570b5fd85.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648759	nitrofurantoin macrocrystals 100 MG Oral Capsule	PSN	dc6bc96c-9a40-469a-9b7c-9cb570b5fd85	1
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	dc6bc96c-9a40-469a-9b7c-9cb570b5fd85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67296-0658-1	67296065801	14 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131	RedPharm Drug Inc. \| TEVA Pharmaceutical Industries Ltd. \| Barr Laboratories Inc.	2011-06-22	HUMAN PRESCRIPTION DRUG LABEL	1