FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
0440-1866
11-digit product format
004401866
Labeler code
0440
Product ID
0440-1866_079d1cdd-ac23-48d6-b2ea-e19287ff77fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA073652
Marketing category
ANDA
Marketing start
2007-03-08
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-1866IInactivated by FDA2026-07-31
excluded packagepackage0440-18660440-1866-20IInactivated by FDA2026-07-31

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
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSProficient Rx LPc87f65b9-14f7-4962-bff6-58b0d1af75f82020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-1866-202020-01-31C16284748780-19d75b9d0-a849-f424-e053-dadaa90a57ceNITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 2131

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1866-20Nitrofurantoin Macrocrystals20 in 1 BOTTLE, PLASTICCAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-1866-20EA - Each0440-1866dcb76f0f-6b2f-472f-9093-054ad750618d12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ONITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1866NITROFURANTOIN MACROCRYSTALS CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20140405_41b65a12-25d4-4e29-ae00-010df78b73ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN41b65a12-25d4-4e29-ae00-010df78b73ed2
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD41b65a12-25d4-4e29-ae00-010df78b73ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1866-200044018662020 in 1 BOTTLE, PLASTICHistorical