FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
47781-308
11-digit product format
477810308
Labeler code
47781
Product ID
47781-308_97785cf3-ab56-4697-3ab6-7451919d889a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA016620
Marketing category
NDA
Marketing start
2010-09-27
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
Rxcui311994, 311995, 1648759

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-308-01nitrofurantoin macrocrystals100 in 1 BOTTLE, PLASTICCAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-308-01EA - Each47781-308a118f3eb-0804-428a-bbfa-4109079c931d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTION MACROCRYSTALS CAPSULE [ALVOGEN INC. ]8
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTION MACROCRYSTALS CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTION MACROCRYSTALS CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-308NITROFURANTOIN MACROCRYSTALS CAPSULE [ALVOGEN INC. ]18Current NDC, Legacy NDC, 1 package rows20241018_62c1bb9c-79a2-41e3-9dfa-352f92253881.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN62c1bb9c-79a2-41e3-9dfa-352f9225388119
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD62c1bb9c-79a2-41e3-9dfa-352f9225388119
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSY62c1bb9c-79a2-41e3-9dfa-352f9225388119
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY62c1bb9c-79a2-41e3-9dfa-352f9225388119
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN3b53f9bf-866a-4cb1-9180-7b13896e26ba6
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD3b53f9bf-866a-4cb1-9180-7b13896e26ba6
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN137b8d13-2e41-4990-8714-4c66c3982be85
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNf78102eb-cbed-801a-e053-6294a90ab8805
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDf78102eb-cbed-801a-e053-6294a90ab8805
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD137b8d13-2e41-4990-8714-4c66c3982be85
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN66474d1d-afc8-f611-e053-2a91aa0acbf53
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD66474d1d-afc8-f611-e053-2a91aa0acbf53
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNb7581146-886b-4fd3-aa64-2e6dc6832aee2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDb7581146-886b-4fd3-aa64-2e6dc6832aee2
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN3281e6f9-c147-4473-8617-e0ad3352a8481
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNd4b372d8-88f8-42c2-87ea-61302258c9171
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN27fa784f-0859-0b97-e054-00144ff8d46c1
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD3281e6f9-c147-4473-8617-e0ad3352a8481
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD27fa784f-0859-0b97-e054-00144ff8d46c1
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDd4b372d8-88f8-42c2-87ea-61302258c9171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-308-0147781030801100 CAPSULE in 1 BOTTLE, PLASTIC (47781-308-01) 100 capsule2010-09-270000-00-00NoNoCurrent