Nitrofurantoin Monohydrate/ Macrocrystalline

Product NDC: 10544-086
11-digit product format: 105440086
Labeler code: 10544
Product ID: 10544-086_1168f072-08bf-485c-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: NDA020064
Marketing category: NDA
Marketing start: 2012-09-06
Marketing end: 0000-00-00
Substance: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-086		I	Inactivated by FDA		2026-08-17
excluded package	package	10544-086	10544-086-14	I	Inactivated by FDA		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 · 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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	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	10544-086-14	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-086-14	2020-01-31	C162847	48780-1	9d75b9d0-f88f-f424-e053-dadaa90a57ce	Nitrofurantoin Monohydrate/Macrocrystals Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-086-14	Nitrofurantoin Monohydrate/ Macrocrystalline	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 MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
NITROFURANTOIN MONOHYDRATE	ACTIVE INGREDIENT	E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-086	NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20150316_1168f072-08be-485c-e054-00144ff8d46c.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
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	1168f072-08be-485c-e054-00144ff8d46c	1
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	1168f072-08be-485c-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-086-14	10544008614	14 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Monohydrate/Macrocrystals Capsules	Blenheim Pharmacal, Inc.	2015-03-16	HUMAN PRESCRIPTION DRUG LABEL	1