Nitrofurantoin Macrocrystals

Product NDC
72789-270
11-digit product format
727890270
Labeler code
72789
Product ID
72789-270_40babafa-2375-c7ba-e063-6394a90aa3e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2007-03-08
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
927AH8112LNITROFURANTOIN67-20-9NITROFURANTOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-270-02727890270022 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-02) 2 capsule2023-01-05NoNoHistorical
72789-270-107278902701010 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-10) 10 capsule2022-09-01NoNoHistorical
72789-270-147278902701414 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-14) 14 capsule2022-09-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL18
NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx onlyPD-Rx Pharmaceuticals, Inc.2024-02-16HUMAN PRESCRIPTION DRUG LABEL17