FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
68071-2517
Requested package NDC
68071-2517-8
11-digit product format
680712517
Labeler code
68071
Product ID
68071-2517_ca56360b-c128-b093-e053-2995a90ace1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare 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
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 packagepackage68071-251768071-2517-8DDiscontinued by firm2026-08-03

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2517-22025-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-62025-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-72025-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-82025-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-22023-05-19C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-62023-05-19C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-72023-05-19C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-82023-05-19C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-22023-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-62023-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-72023-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only
68071-2517-82023-01-30C16284748780-1f386c64a-2f57-0266-e053-dadaa90a7c1aNITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2517-2Nitrofurantoin Macrocrystals20 in 1 BOTTLECAPSULE202
68071-2517-6Nitrofurantoin Macrocrystals6 in 1 BOTTLECAPSULE62
68071-2517-7Nitrofurantoin Macrocrystals14 in 1 BOTTLECAPSULE142
68071-2517-8Nitrofurantoin Macrocrystals28 in 1 BOTTLECAPSULE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2517NITROFURANTOIN MACROCRYSTALS CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 4 package rows20230520_ca55d17a-6491-c495-e053-2a95a90a6845.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2517-86807125170828 CAPSULE in 1 BOTTLE (68071-2517-8) 28 capsule2021-08-240000-00-00NoNoCurrent