FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
70771-1170
11-digit product format
707711170
Labeler code
70771
Product ID
70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205005
Marketing category
ANDA
Marketing start
2018-02-15
Substance
NITROFURANTOIN
Active strength
50 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205005-001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE50MGCAPSULE / ORALAB2017-12-12
A205005-002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE100MGCAPSULE / ORALAB2017-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205005-001AB
A205005-002AB

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 22:54:322026-06A205005-001NITROFURANTOIN50MGCAPSULE / ORALAB2017-12-12a50c72e98297…
2026-08-01 22:54:322026-06A205005-002NITROFURANTOIN100MGCAPSULE / ORALAB2017-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205005-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205005-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSMajor Pharmaceuticals3ee5e79f-1dca-4e1b-95a9-7859bfe344d12026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205005
application number: ANDA205005
nitrofurantoinNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackaca04d52-8a64-4fca-94b2-64b46f5a32182024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205005
application number: ANDA205005
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSZydus Pharmaceuticals (USA) Inc.2862e49a-66e9-4418-9343-4404036775fc2023-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205005
application number: ANDA205005
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSZydus Lifesciences Limited8124bb9f-66af-4251-86b0-d1c247cdcb632023-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205005
application number: ANDA205005
ndc (product): 70771-1170

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN50 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311995Internal RxNorm lookup
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
8124bb9f-66af-4251-86b0-d1c247cdcb63Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1170-0nitrofurantoin macrocrystals1000 in 1 BOTTLECAPSULE10006
70771-1170-1nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1006
70771-1170-2nitrofurantoin macrocrystals10 in 1 CARTONCAPSULE106
70771-1170-2nitrofurantoin macrocrystals10 in 1 BLISTER PACKCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1170NITROFURANTOIN MACROCRYSTALS CAPSULE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 4 package rows20231122_8124bb9f-66af-4251-86b0-d1c247cdcb63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN8124bb9f-66af-4251-86b0-d1c247cdcb636
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSN8124bb9f-66af-4251-86b0-d1c247cdcb636
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD8124bb9f-66af-4251-86b0-d1c247cdcb636
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCD8124bb9f-66af-4251-86b0-d1c247cdcb636
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSY8124bb9f-66af-4251-86b0-d1c247cdcb636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1170-0707711170001000 CAPSULE in 1 BOTTLE (70771-1170-0) 1000 capsule2018-02-150000-00-00NoNoCurrent
70771-1170-170771117001100 CAPSULE in 1 BOTTLE (70771-1170-1) 100 capsule2018-02-150000-00-00NoNoCurrent
70771-1170-27077111700210 BLISTER PACK in 1 CARTON (70771-1170-2) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2018-02-150000-00-00NoNoCurrent