Nitrofurantoin Macrocrystals

Product NDC
71205-297
11-digit product format
712050297
Labeler code
71205
Product ID
71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-297-10Nitrofurantoin Macrocrystals10 in 1 BOTTLECAPSULE103
71205-297-14Nitrofurantoin Macrocrystals14 in 1 BOTTLECAPSULE143
71205-297-20Nitrofurantoin Macrocrystals20 in 1 BOTTLECAPSULE203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-297-14EA - Each71205-297a39e8517-9310-4dfa-9f70-89aa8e58a65812019-10-07
71205-297-20EA - Each71205-297fe01e89f-3cca-4e58-bda6-efe986b6daa412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-297NITROFURANTOIN MACROCRYSTALS CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20200111_c87f65b9-14f7-4962-bff6-58b0d1af75f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNc87f65b9-14f7-4962-bff6-58b0d1af75f83
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDc87f65b9-14f7-4962-bff6-58b0d1af75f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-297-107120502971010 CAPSULE in 1 BOTTLE (71205-297-10) 10 capsule2019-07-010000-00-00NoNoCurrent
71205-297-147120502971414 CAPSULE in 1 BOTTLE (71205-297-14) 14 capsule2019-07-010000-00-00NoNoCurrent
71205-297-207120502972020 CAPSULE in 1 BOTTLE (71205-297-20) 20 capsule2019-07-010000-00-00NoNoCurrent