Home NDC 59651-753 nitrofurantoin (macrocrystals)
Product NDC 59651-753
11-digit product format 596510753
Labeler code 59651
Product ID 59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitrofurantoin (macrocrystals)
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA074967
Marketing category ANDA
Marketing start 2023-05-12
Substance NITROFURANTOIN
Active strength 50 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 42 .
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.
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 · 84 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 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…2019-12-13 00:20 UTC 2019-12 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074967-001 NITROFURANTOIN 50MG CAPSULE / ORAL 1997-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074967-002 NITROFURANTOIN 100MG CAPSULE / ORAL 1997-07-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
Additional Listing Data#
Finished product Yes
Brand name base nitrofurantoin (macrocrystals)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN 50 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 311995 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-753-01 nitrofurantoin (macrocrystals) 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-753 NITROFURANTOIN (MACROCRYSTALS) CAPSULE [AUROBINDO PHARMA LIMITED] 2 Current NDC, 1 package rows 20230526_158e08ff-9b6d-4d60-a218-74dc289cf023.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-753-01 59651075301 100 CAPSULE in 1 BOTTLE (59651-753-01) 100 capsule 2023-05-12 No No Current