FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
71335-1135
11-digit product format
713351135
Labeler code
71335
Product ID
71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073652-001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE100MGCAPSULE / ORALAB1993-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A073652-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A073652-001NITROFURANTOIN100MGCAPSULE / ORALAB1993-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073652-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSPD-Rx Pharmaceuticals, Inc.536ed022-db80-492d-b6ab-809855ea90fb2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmneal Pharmaceuticals of New York LLC341c75ac-fba5-480d-a221-868c4195cb6f2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAvPAK650f3c60-d45d-4358-a388-7efee4ad04972026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSRedpharm Drug32520c80-0ce5-ea4b-e063-6294a90a37ba2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
NitrofurantoinNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackc335f76b-6b85-4c9f-bbfa-95514cdd80fa2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
ndc (product): 71335-1135
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSProficient Rx LPc87f65b9-14f7-4962-bff6-58b0d1af75f82020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
927AH8112LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648759Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c335f76b-6b85-4c9f-bbfa-95514cdd80faAvailable on FDA.report

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
71335-1135-1Nitrofurantoin40 in 1 BOTTLECAPSULE406
71335-1135-2Nitrofurantoin28 in 1 BOTTLECAPSULE286
71335-1135-3Nitrofurantoin30 in 1 BOTTLECAPSULE306
71335-1135-4Nitrofurantoin20 in 1 BOTTLECAPSULE206
71335-1135-5Nitrofurantoin14 in 1 BOTTLECAPSULE146
71335-1135-6Nitrofurantoin10 in 1 BOTTLECAPSULE106
71335-1135-7Nitrofurantoin12 in 1 BOTTLECAPSULE126
71335-1135-8Nitrofurantoin90 in 1 BOTTLECAPSULE906
71335-1135-9Nitrofurantoin6 in 1 BOTTLECAPSULE66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1135NITROFURANTOIN (NITROFURANTOIN MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240410_c335f76b-6b85-4c9f-bbfa-95514cdd80fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNc335f76b-6b85-4c9f-bbfa-95514cdd80fa6
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDc335f76b-6b85-4c9f-bbfa-95514cdd80fa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1135-17133511350140 CAPSULE in 1 BOTTLE (71335-1135-1) 40 capsule2024-04-020000-00-00NoNoCurrent
71335-1135-27133511350228 CAPSULE in 1 BOTTLE (71335-1135-2) 28 capsule2019-04-020000-00-00NoNoCurrent
71335-1135-37133511350330 CAPSULE in 1 BOTTLE (71335-1135-3) 30 capsule2024-04-020000-00-00NoNoCurrent
71335-1135-47133511350420 CAPSULE in 1 BOTTLE (71335-1135-4) 20 capsule2019-07-090000-00-00NoNoCurrent
71335-1135-57133511350514 CAPSULE in 1 BOTTLE (71335-1135-5) 14 capsule2019-02-280000-00-00NoNoCurrent
71335-1135-67133511350610 CAPSULE in 1 BOTTLE (71335-1135-6) 10 capsule2019-03-200000-00-00NoNoCurrent
71335-1135-77133511350712 CAPSULE in 1 BOTTLE (71335-1135-7) 12 capsule2024-04-020000-00-00NoNoCurrent
71335-1135-87133511350890 CAPSULE in 1 BOTTLE (71335-1135-8) 90 capsule2024-04-020000-00-00NoNoCurrent
71335-1135-9713351135096 CAPSULE in 1 BOTTLE (71335-1135-9) 6 capsule2021-09-090000-00-00NoNoCurrent