FDA.reportPublic FDA data

Nitrofurantoin Macrocrystals

Product NDC
60687-316
11-digit product format
606870316
Labeler code
60687
Product ID
60687-316_7016ed20-f357-b3be-e053-2a91aa0a04e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA073652
Marketing category
ANDA
Marketing start
2018-06-21
Marketing end
2020-06-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60687-316DDiscontinued by firm2026-08-03
excluded packagepackage60687-31660687-316-01DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-316-01EA - Each60687-31604296800-d37f-4171-9847-ff992f95db4f12018-07-03
60687-316-11EA - Each60687-3166aaffc5e-e064-402c-b6d6-6562bd73f50912018-07-03