Nitrofurantoin Macrocrystals

Product NDC: 71205-297
11-digit product format: 712050297
Labeler code: 71205
Product ID: 71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin Macrocrystals
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA073652
Marketing category: ANDA
Marketing start: 2007-03-08
Substance: NITROFURANTOIN
Active strength: 100 mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-11-08 22:44 UTC · 2 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…`
2022-09-29 23:25 UTC	2022-09	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A073652-001	NITROFURANTOIN	100MG	CAPSULE / ORAL	AB	1993-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 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…`
2022-09-29 23:25 UTC	2022-09	A073652-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073652-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A073652-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 71205-297

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantoin Macrocrystals
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
927AH8112L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648759	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c87f65b9-14f7-4962-bff6-58b0d1af75f8	Available on FDA.report

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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-297-10	Nitrofurantoin Macrocrystals	10 in 1 BOTTLE	CAPSULE	10	3
71205-297-14	Nitrofurantoin Macrocrystals	14 in 1 BOTTLE	CAPSULE	14	3
71205-297-20	Nitrofurantoin Macrocrystals	20 in 1 BOTTLE	CAPSULE	20	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-297-14	EA - Each	71205-297	a39e8517-9310-4dfa-9f70-89aa8e58a658	1	2019-10-07
71205-297-20	EA - Each	71205-297	fe01e89f-3cca-4e58-bda6-efe986b6daa4	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-297	NITROFURANTOIN MACROCRYSTALS CAPSULE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20200111_c87f65b9-14f7-4962-bff6-58b0d1af75f8.zip

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	c87f65b9-14f7-4962-bff6-58b0d1af75f8	3
1648759	nitrofurantoin, macrocrystals 100 MG Oral Capsule	SCD	c87f65b9-14f7-4962-bff6-58b0d1af75f8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-297-10	71205029710	10 CAPSULE in 1 BOTTLE (71205-297-10)	10 capsule	2019-07-01	0000-00-00	No	No	Current
71205-297-14	71205029714	14 CAPSULE in 1 BOTTLE (71205-297-14)	14 capsule	2019-07-01	0000-00-00	No	No	Current
71205-297-20	71205029720	20 CAPSULE in 1 BOTTLE (71205-297-20)	20 capsule	2019-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITROFURANTOIN CAPSULES USP (Macrocrystals) 50 mg and 100 mg Rx only	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	3