Home NDC 68788-7276 Nitrofurantoin
Product NDC 68788-7276
11-digit product format 687887276
Labeler code 68788
Product ID 68788-7276_1fe556e6-94ba-4e28-8b04-1625fe8a953b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrofurantoin monohydrate/macrocrystals
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA207372
Marketing category ANDA
Marketing start 2020-06-01
Marketing end 0000-00-00
Substance NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength 75 mg/1; mg/1
Pharmacologic classes Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE / ORAL 2017-05-15
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 · 43 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 2026-09-14 22:38:34 2026-08 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL 2017-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207372-001 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 75MG;25MG CAPSULE / ORAL AB 2017-05-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7276-0 68788727600 10 CAPSULE in 1 BOTTLE (68788-7276-0) 10 capsule 2020-06-01 0000-00-00 No No Current 68788-7276-1 68788727601 14 CAPSULE in 1 BOTTLE (68788-7276-1) 14 capsule 2020-06-01 0000-00-00 No No Current