Home NDC 71335-1069-5 nitrofurantoin
Product NDC 71335-1069
Requested package NDC 71335-1069-5
11-digit product format 713351069
Labeler code 71335
Product ID 71335-1069_05e89273-b886-40bb-be42-7807d29f5dee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitrofurantoin macrocrystals
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA205005
Marketing category ANDA
Marketing start 2018-02-15
Substance NITROFURANTOIN
Active strength 100 mg/1
Pharmacologic classes Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-1069 71335-1069-5 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-1069 71335-1069-5 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A205005-001 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE / ORAL AB 2017-12-12 A205005-002 NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE / ORAL AB 2017-12-12
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 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205005-001 NITROFURANTOIN 50MG CAPSULE / ORAL AB 2017-12-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205005-002 NITROFURANTOIN 100MG CAPSULE / ORAL AB 2017-12-12 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROFURANTOIN 100 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 1648759 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1069-1 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-2 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-3 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-4 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-5 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-6 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-7 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-8 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-9 2024-05-20 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-1 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-2 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-3 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-4 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-5 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-6 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-7 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-8 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only 71335-1069-9 2024-01-30 Nitrofurantoin Capsules, USP (Macrocrystals) Rx only
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1069 NITROFURANTOIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK] 3 Current NDC, Legacy NDC, 9 package rows 20240522_aca04d52-8a64-4fca-94b2-64b46f5a3218.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 · 4 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 71335-1069-5 71335106905 14 CAPSULE in 1 BOTTLE (71335-1069-5) 14 capsule 2019-01-21 0000-00-00 No No Current