Nitrofurantoin

Product NDC
71205-852
11-digit product format
712050852
Labeler code
71205
Product ID
71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui1648755

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cfProduct name620251106
f6207266-e92b-4b5b-a91b-4af4215c9542Product name620240813
e31776f7-6119-9577-e170-5b569993276eProduct name520240320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-852-00Nitrofurantoin100 in 1 BOTTLECAPSULE1001
71205-852-10Nitrofurantoin10 in 1 BOTTLECAPSULE101
71205-852-14Nitrofurantoin14 in 1 BOTTLECAPSULE141
71205-852-20Nitrofurantoin20 in 1 BOTTLECAPSULE201
71205-852-30Nitrofurantoin30 in 1 BOTTLECAPSULE301
71205-852-55Nitrofurantoin500 in 1 BOTTLECAPSULE5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-852NITROFURANTOIN CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 6 package rows20221124_34d3c103-27b8-454b-9f38-c33157c3b6fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN34d3c103-27b8-454b-9f38-c33157c3b6fc1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD34d3c103-27b8-454b-9f38-c33157c3b6fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-852-0071205085200100 CAPSULE in 1 BOTTLE (71205-852-00) 100 capsule2022-11-230000-00-00NoNoCurrent
71205-852-107120508521010 CAPSULE in 1 BOTTLE (71205-852-10) 10 capsule2022-11-230000-00-00NoNoCurrent
71205-852-147120508521414 CAPSULE in 1 BOTTLE (71205-852-14) 14 capsule2022-11-230000-00-00NoNoCurrent
71205-852-207120508522020 CAPSULE in 1 BOTTLE (71205-852-20) 20 capsule2022-11-230000-00-00NoNoCurrent
71205-852-307120508523030 CAPSULE in 1 BOTTLE (71205-852-30) 30 capsule2022-11-230000-00-00NoNoCurrent
71205-852-5571205085255500 CAPSULE in 1 BOTTLE (71205-852-55) 500 capsule2022-11-230000-00-00NoNoCurrent