Nitrofurantoin (monohydrate/macrocrystals)

Product NDC: 68071-4428
11-digit product format: 680714428
Labeler code: 68071
Product ID: 68071-4428_1a8c366e-d568-fc06-e063-6394a90abec9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin (monohydrate/macrocrystals)
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077066
Marketing category: ANDA
Marketing start: 2005-04-06
Marketing end: 2027-03-18
Substance: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength: 25; 75 mg/1; mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag: No
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
A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2005-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077066-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2005-04-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077066-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077066-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077066-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077066-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077066-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077066-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077066-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077066-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077066-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077066-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077066-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077066-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077066-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077066-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077066-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077066-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077066-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077066-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077066-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077066-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077066-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077066-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077066-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077066-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077066-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077066-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077066-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077066-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077066-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077066-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077066-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077066-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077066-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077066-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077066-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077066-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077066-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077066-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077066-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077066-001	AB	1	`cb3db0bc1861…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	ae892973-9ef4-4cf0-baf3-fbe158697bac	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	St. Mary's Medical Park Pharmacy	87210c87-b7db-0f65-e053-2a91aa0a4393	2026-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	0631d961-ef23-8f2a-e063-6294a90aa0a8	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	7767697f-4dd0-477d-b5cc-e1ed5689f097	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	PD-Rx Pharmaceuticals, Inc.	643cdcff-8599-4326-b3ca-d9fd270e0fc2	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Northwind Health Company, LLC	04b4189e-9b21-78ed-e063-6394a90ab8e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	QPharma, Inc.	fbc05ccb-782b-55f6-e053-6394a90a7fd6	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	A-S Medication Solutions	b644426c-c8ba-4fe0-80c7-d9b2dde37395	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
NITROFURANTOIN	NITROFURANTOIN	Directrx	d4385368-46d6-8397-e053-2a95a90a8d68	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	68a651f9-1aef-792e-e053-2991aa0a3cbb	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	6bccbaab-151b-4a04-e053-2991aa0ae105	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066 ndc (product): 68071-4428
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Sandoz Inc	7ba9a729-a73a-4a13-a336-0284cc8a67e1	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	05f4b126-0fb9-5ee9-c89c-f229e60f84e3	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Asclemed USA, Inc.	1ab658f0-021a-46a1-bff3-d3334c23442d	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	d802d734-dc8f-4f3c-bce6-aaccc4614c89	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077066 application number: ANDA077066

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantoin (monohydrate/macrocrystals)

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN MONOHYDRATE	25 mg/1
NITROFURANTOIN	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E1QI2CQQ1I	Internal UNII lookup
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
1648755	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
6bccbaab-151b-4a04-e053-2991aa0ae105	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4428-2	2023-03-10	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-6	2023-03-10	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-2	2023-01-30	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-6	2023-01-30	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-2	2020-02-18	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-6	2020-02-18	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-2	2020-01-31	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)
68071-4428-6	2020-01-31	C162847	48780-1	9d75b9d0-24eb-f424-e053-dadaa90a57ce	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4428-2	Nitrofurantoin (monohydrate/macrocrystals)	2 in 1 BOTTLE	CAPSULE	2		5
68071-4428-6	Nitrofurantoin (monohydrate/macrocrystals)	6 in 1 BOTTLE	CAPSULE	6		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4428	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240710_6bccbaab-151b-4a04-e053-2991aa0ae105.zip

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	6bccbaab-151b-4a04-e053-2991aa0ae105	5
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	6bccbaab-151b-4a04-e053-2991aa0ae105	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4428-2	68071442802	2 CAPSULE in 1 BOTTLE (68071-4428-2)	2 capsule	2018-05-09	2027-03-18	No	No	Current
68071-4428-6	68071442806	6 CAPSULE in 1 BOTTLE (68071-4428-6)	6 capsule	2018-05-09	2027-03-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5