Nitrofurantoin (macrocrystals)

Product NDC: 0378-1650
11-digit product format: 003781650
Labeler code: 0378
Product ID: 0378-1650_808bdd29-3806-4d9d-8701-9a898ef9a916
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitrofurantoin (macrocrystals)
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074967
Marketing category: ANDA
Marketing start: 1997-09-09
Marketing end: 2019-08-31
Substance: NITROFURANTOIN
Active strength: 50 mg/1
Pharmacologic classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-1650		D	Discontinued by firm	2026-10-16
excluded package	package	0378-1650	0378-1650-01	D	Discontinued by firm	2026-10-16
excluded package	package	0378-1650	0378-1650-05	D	Discontinued by firm	2026-10-16

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 · 36 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	0378-1650-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-1650-05	`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	0378-1650-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-1650-05	`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	0378-1650-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-1650-05	`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	0378-1650-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-1650-05	`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	0378-1650-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-1650-05	`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	0378-1650-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-1650-05	`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	0378-1650-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-1650-05	`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	0378-1650-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-1650-05	`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	0378-1650-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-1650-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-1650-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-1650-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-1650-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-1650-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-1650-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-1650-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074967-001	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE / ORAL	AB		1997-07-09
A074967-002	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE / ORAL	AB		1997-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074967-001	AB
A074967-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL	AB	1997-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1997-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL		1997-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL		1997-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL		1997-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL		1997-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074967-001	NITROFURANTOIN	50MG	CAPSULE / ORAL		1997-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074967-002	NITROFURANTOIN	100MG	CAPSULE / ORAL		1997-07-09	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A074967-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074967-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074967-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074967-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074967-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074967-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074967-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074967-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074967-002	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074967-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074967-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1650-01	EA - Each	0378-1650	d56ee91f-e27c-4441-9324-24e92a4550b3	1	2012-07-24
0378-1650-05	EA - Each	0378-1650	ef27b64e-9aee-477d-b062-970af0d5f366	1	2012-07-24

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitrofurantoin (macrocrystals)	NITROFURANTOIN (MACROCRYSTALS)	Aurobindo Pharma Limited	158e08ff-9b6d-4d60-a218-74dc289cf023	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074967 application number: ANDA074967