Home NDC 43386-450 Nitrofurantoin
Product NDC 43386-450
11-digit product format 433860450
Labeler code 43386
Product ID 43386-450_361dd255-19ba-453f-9b68-ade3185ff390
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin
Dosage form SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA201693
Marketing category ANDA
Marketing start 2015-05-21
Substance NITROFURANTOIN
Active strength 25 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201693-001 NITROFURANTOIN NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201693-001 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 · 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 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201693-001 NITROFURANTOIN 25MG/5ML SUSPENSION / ORAL AB 2014-09-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nitrofurantoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN 25 mg/5mL
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 311989 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 43386-450-11 Nitrofurantoin 230 mL in 1 BOTTLE SUSPENSION 230 3 43386-450-11 Nitrofurantoin 1 in 1 CARTON SUSPENSION 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NITROFURANTOIN ACTIVE INGREDIENT 927AH8112L NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 NITROFURANTOIN ACTIVE MOIETY 927AH8112L NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NITROFURANTOIN SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-450 NITROFURANTOIN SUSPENSION [LUPIN PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230625_93c37857-38f1-4e2e-acb8-4846840e3e85.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 · 2 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 43386-450-11 43386045011 1 BOTTLE in 1 CARTON (43386-450-11) / 230 mL in 1 BOTTLE 1 bottle 2015-05-21 0000-00-00 No No Current