FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
0904-7025
Requested package NDC
0904-7025-61
11-digit product format
009047025
Labeler code
0904
Product ID
0904-7025_7bf3f966-daf0-49a5-943b-d640cd54d8b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205005
Marketing category
ANDA
Marketing start
2018-02-15
Marketing end
2022-04-30
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-70250904-7025-61DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7025-61EA - Each0904-702555fcd3e0-d1c5-48a6-894f-c77a60f5028212020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7025-6100904702561100 BLISTER PACK in 1 CARTON (0904-7025-61) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2018-02-152022-04-30NoNoCurrent