FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
68071-4688
Requested package NDC
68071-4688-7
11-digit product format
680714688
Labeler code
68071
Product ID
68071-4688_bb8bc444-d1e7-a08f-e053-2a95a90a4446
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205005
Marketing category
ANDA
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-468868071-4688-7DDiscontinued 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4688-72024-06-12C16284748780-1ba0f9c33-4d9c-a910-e053-dadaa90a0b85Nitrofurantoin Capsules, USP (Macrocrystals) Rx only
68071-4688-72023-01-30C16284748780-1ba0f9c33-4d9c-a910-e053-dadaa90a0b85Nitrofurantoin Capsules, USP (Macrocrystals) Rx only
68071-4688-72021-02-17C16284748780-1ba0f9c33-4d9c-a910-e053-dadaa90a0b85Nitrofurantoin Capsules, USP (Macrocrystals) Rx only
68071-4688-72021-01-29C16284748780-1ba0f9c33-4d9c-a910-e053-dadaa90a0b85Nitrofurantoin Capsules, USP (Macrocrystals) Rx only

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4688-76807146880714 CAPSULE in 1 BOTTLE (68071-4688-7) 14 capsule2019-01-020000-00-00NoNoCurrent