FDA.reportPublic FDA data

Application 073652

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL100MGNoNo

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
ndc (product): 72789-270
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmneal Pharmaceuticals of New York LLC341c75ac-fba5-480d-a221-868c4195cb6f2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
ndc (product): 0115-1645
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAvPAK650f3c60-d45d-4358-a388-7efee4ad04972026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073652
application number: ANDA073652
ndc (product): 50268-624
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
ndc (product): 71205-297

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0440-1866Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsLiberty Pharmaceuticals, Inc.ANDACurrent
10544-601Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsBlenheim Pharmacal, Inc.ANDACurrent
42254-070Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsRebel Distributors CorpANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50436-6591Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsUnit Dose ServicesANDACurrent
60687-316Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingANDACurrent
67296-0658Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsRedPharm Drug Inc.ANDACurrent
68071-2517Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4644Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4644Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4681Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71335-1135NitrofurantoinNitrofurantoin MacrocrystalsBryant Ranch PrepackANDACurrent
71335-1135NitrofurantoinNitrofurantoin MacrocrystalsBryant Ranch PrepackANDACurrent
72789-270Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-270Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.ANDACurrent