Nitrofurantoin Macrocrystals

Product NDC: 63629-4792
11-digit product format: 636294792
Labeler code: 63629
Product ID: 63629-4792_e315a2e3-3a25-4b2b-8791-c373aaf308d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA073671
Marketing category: ANDA
Marketing start: 2007-03-08
Marketing end: 0000-00-00
Substance: NITROFURANTOIN
Active strength: 50 mg/1
Pharmacologic classes: 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4792		D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-5	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4792	63629-4792-6	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 2 · 99 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4792-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4792-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4792-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4792-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4792-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4792-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4792-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4792-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4792-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4792-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4792-1	`0efc9e666f02…`	`f202fb6c5f17…`

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
A073671-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	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
A073671-001	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	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073671-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1993-01-28	`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	A073671-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073671-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073671-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073671-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073671-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073671-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073671-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073671-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073671-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073671-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073671-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073671-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073671-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073671-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073671-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073671-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073671-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073671-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073671-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073671-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073671-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073671-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073671-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073671-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073671-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073671-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073671-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073671-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073671-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073671-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073671-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073671-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073671-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073671-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073671-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073671-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073671-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073671-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073671-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073671-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4792-1	2021-07-01	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-2	2021-07-01	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-3	2021-07-01	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-4	2021-07-01	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-1	2019-11-27	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-2	2019-11-27	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-3	2019-11-27	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131
63629-4792-4	2019-11-27	NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROFURANTOIN	ACTIVE INGREDIENT	927AH8112L	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
NITROFURANTOIN	ACTIVE MOIETY	927AH8112L	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]	1002

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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): 073671 application number: ANDA073671
Nitrofurantoin Macrocrystals	NITROFURANTOIN MACROCRYSTALS	AvPAK	650f3c60-d45d-4358-a388-7efee4ad0497	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073671 application number: ANDA073671

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131	Bryant Ranch Prepack	2014-07-28	HUMAN PRESCRIPTION DRUG LABEL	1002