Home NDC 65162-478 Nitrofurantoin
Product NDC 65162-478
11-digit product format 651620478
Labeler code 65162
Product ID 65162-478_12c7ce84-65f3-4970-bdaf-b3c169294561
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin monohydrate/macrocrystals
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA207372
Marketing category ANDA
Marketing start 2017-05-25
Marketing end 0000-00-00
Substance NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength 25 mg/1; mg/1
Pharmacologic classes Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE / ORAL 2017-05-15
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 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nitrofurantoin
Brand name suffix (monohydrate/macrocrystals) Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN MONOHYDRATE 75 mg/1 NITROFURANTOIN 25 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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-478 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMNEAL PHARMACEUTICALS LLC] 19 Legacy NDC 20241031_55c75f27-b5fc-4f19-8607-08f8ec0c69ec.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 · 1 matching rows.
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 58614369-f5ac-4d38-9fb8-2383b791eb71 5 1648755 nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule SCD 58614369-f5ac-4d38-9fb8-2383b791eb71 5 1648755 nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule PSN 0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f 3 1648755 nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule PSN 2bedff75-22c8-49cf-b2e6-8471fd69055c 3 1648755 nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule SCD 0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f 3 1648755 nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule SCD 2bedff75-22c8-49cf-b2e6-8471fd69055c 3 1648755 nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule PSN 88de4809-bcbd-02ab-e053-2a95a90a4e88 2 1648755 nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule SCD 88de4809-bcbd-02ab-e053-2a95a90a4e88 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-478-10 65162047810 100 CAPSULE in 1 BOTTLE (65162-478-10) 100 capsule 2017-05-25 0000-00-00 No No Current