Home NDC 43386-641 Nitrofurantoin macrocrystals
Product NDC 43386-641
11-digit product format 433860641
Labeler code 43386
Product ID 43386-641_2e7ec48f-d605-4e97-8620-299e5f143026
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin macrocrystals
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA203233
Marketing category ANDA
Marketing start 2018-07-09
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 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.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311995 Internal RxNorm lookup 1648759 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 43386-641-01 Nitrofurantoin macrocrystals 100 in 1 BOTTLE CAPSULE 100 3 43386-641-10 Nitrofurantoin macrocrystals 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-641 NITROFURANTOIN MACROCRYSTALS CAPSULE [LUPIN PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240131_52168b36-4e95-4d5b-82be-bbb91c7dcb90.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 43386-641-01 43386064101 100 CAPSULE in 1 BOTTLE (43386-641-01) 100 capsule 2018-07-09 0000-00-00 No No Current 43386-641-10 43386064110 1000 CAPSULE in 1 BOTTLE (43386-641-10) 1000 capsule 2018-07-09 0000-00-00 No No Current