FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927AH8112L
Rxcui1648759

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-270-02Nitrofurantoin Macrocrystals2 in 1 BOTTLE, PLASTICCAPSULE218
72789-270-10Nitrofurantoin Macrocrystals10 in 1 BOTTLE, PLASTICCAPSULE1018
72789-270-14Nitrofurantoin Macrocrystals14 in 1 BOTTLE, PLASTICCAPSULE1418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-270-02EA - Each72789-2704f8f020a-15cc-4678-888a-566fb6630f6112023-02-06
72789-270-10EA - Each72789-270cffe1f1c-095d-4c3e-9630-812fb23fa21112022-10-06
72789-270-14EA - Each72789-2703b9934b7-1c32-4a86-91d8-1362360c104a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-270NITROFURANTOIN MACROCRYSTALS CAPSULE [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 3 package rows20240217_536ed022-db80-492d-b6ab-809855ea90fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN536ed022-db80-492d-b6ab-809855ea90fb18
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD536ed022-db80-492d-b6ab-809855ea90fb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-270-02727890270022 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-02) 2 capsule2023-01-050000-00-00NoNoCurrent
72789-270-107278902701010 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-10) 10 capsule2022-09-010000-00-00NoNoCurrent
72789-270-147278902701414 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-14) 14 capsule2022-09-010000-00-00NoNoCurrent