Home NDC 40032-641-01 Nitrofurantoin macrocrystals
Product NDC 40032-641
Requested package NDC 40032-641-01
11-digit product format 400320641
Labeler code 40032
Product ID 40032-641_7372be05-1fb5-4d62-8380-6007f61c929b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin macrocrystals
Dosage form CAPSULE
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA203233
Marketing category ANDA
Marketing start 2018-07-09
Marketing end 0000-00-00
Substance NITROFURANTOIN
Active strength 50 mg/1
Pharmacologic classes Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A203233-001 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE / ORAL AB 2018-07-09 A203233-002 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE / ORAL AB 2018-07-09
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 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203233-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2018-07-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203233-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2018-07-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-641-01 Nitrofurantoin macrocrystals 100 in 1 BOTTLE CAPSULE 100 5 40032-641-10 Nitrofurantoin macrocrystals 1000 in 1 BOTTLE CAPSULE 1000 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-641 NITROFURANTOIN MACROCRYSTALS CAPSULE [NOVEL LABORATORIES, INC.] 5 Legacy NDC, 2 package rows 20191221_28bb2d0e-f209-49dd-89e0-9eca473164f9.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 Marketing end Sample Exclude flag Status 40032-641-01 40032064101 100 CAPSULE in 1 BOTTLE (40032-641-01) 100 capsule 2018-07-09 0000-00-00 No No Current