FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
68788-8258
11-digit product format
687888258
Labeler code
68788
Product ID
68788-8258_1749c679-6cb0-4a4d-bdae-7e3406a46710
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208516
Marketing category
ANDA
Marketing start
2022-09-16
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
68788-8258-0Nitrofurantoin10 in 1 BOTTLECAPSULE105
68788-8258-1Nitrofurantoin14 in 1 BOTTLECAPSULE145
68788-8258-8Nitrofurantoin28 in 1 BOTTLECAPSULE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8258-0EA - Each68788-8258b29d5013-7e21-4ed3-833a-55cbd3c522aa12022-10-06
68788-8258-1EA - Each68788-82580b790a87-aac4-471e-8516-7b2cab49f0b712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8258NITROFURANTOIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240725_729f6bbb-ab64-4b65-979a-4ad7605c5947.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN729f6bbb-ab64-4b65-979a-4ad7605c59475
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD729f6bbb-ab64-4b65-979a-4ad7605c59475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8258-06878882580010 CAPSULE in 1 BOTTLE (68788-8258-0) 10 capsule2022-09-160000-00-00NoNoCurrent
68788-8258-16878882580114 CAPSULE in 1 BOTTLE (68788-8258-1) 14 capsule2022-09-160000-00-00NoNoCurrent
68788-8258-86878882580828 CAPSULE in 1 BOTTLE (68788-8258-8) 28 capsule2023-08-15NoNoHistorical