FDA.reportPublic FDA data

nitrofurantoin macrocrystals

Product NDC
68001-603
11-digit product format
680010603
Labeler code
68001
Product ID
68001-603_471a5d83-5cd5-cebe-e063-6394a90a16ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-10-11
Substance
NITROFURANTOIN
Active strength
25 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217272-001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE25MGCAPSULE / ORALAB2023-03-21
A217272-002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE50MGCAPSULE / ORALAB2023-03-21
A217272-003NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE100MGCAPSULE / ORALAB2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217272-001AB
A217272-002AB
A217272-003AB

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 22:54:322026-06A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21a50c72e98297…
2026-08-01 22:54:322026-06A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21a50c72e98297…
2026-08-01 22:54:322026-06A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217272-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217272-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217272-003AB1a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBluePoint Laboratoriescfa20cfd-478f-48c6-9b59-3c425abd766a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
ndc (product): 68001-603
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSREMEDYREPACK INC.27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a12026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSRedpharm Drug52eea406-abb9-2713-e063-6294a90a00c62026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSDirect_Rx10d05283-e247-4e60-e063-6294a90ac2922026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSNorthwind Health Company, LLC075fe819-fc4f-2dce-e063-6294a90ad8232025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSVERITYRX, LLC42a1c744-93dc-31cc-e063-6294a90ab9122025-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSPD-Rx Pharmaceuticals, Inc.f28d72be-56d7-467f-a3f8-9ffd57d0dffa2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSProficient Rx LPef7053f3-3081-49c4-9c78-d40a01177fd92024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoinNITROFURANTOIN MACROCRYSTALSA-S Medication Solutions4cd9e234-a2b9-4201-b8f8-cf37c0672de72024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmerican Health Packagingce4afef1-22c1-4a1c-a102-a32fb6a2e0452024-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSNorthStar RxLLC1e3c284a-539d-4923-a5f6-547390baf8112023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackaf291b9c-d1b4-42c3-a1e9-bdf3b63fd7e62023-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepack4bac93c7-dd35-4f5a-8067-5c6fcccc729d2023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSLifestar Pharma LLC6ec66cc8-938f-4839-98c7-a51c9f1d50ed2023-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272

Additional Listing Data#

Finished product
Yes
Brand name base
nitrofurantoin macrocrystals
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311994Internal RxNorm lookup
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
cfa20cfd-478f-48c6-9b59-3c425abd766aAvailable 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
68001-603-00nitrofurantoin macrocrystals100 in 1 BOTTLECAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-603-00EA - Each68001-6035cb8775b-b2ef-4c13-8d4b-de0c3d274c7312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-603NITROFURANTOIN MACROCRYSTALS CAPSULE [BLUEPOINT LABORATORIES]2Current NDC, 1 package rows20231107_cfa20cfd-478f-48c6-9b59-3c425abd766a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNcfa20cfd-478f-48c6-9b59-3c425abd766a4
311994nitrofurantoin macrocrystals 25 MG Oral CapsulePSNcfa20cfd-478f-48c6-9b59-3c425abd766a4
311995nitrofurantoin macrocrystals 50 MG Oral CapsulePSNcfa20cfd-478f-48c6-9b59-3c425abd766a4
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDcfa20cfd-478f-48c6-9b59-3c425abd766a4
311994nitrofurantoin, macrocrystals 25 MG Oral CapsuleSCDcfa20cfd-478f-48c6-9b59-3c425abd766a4
311995nitrofurantoin, macrocrystals 50 MG Oral CapsuleSCDcfa20cfd-478f-48c6-9b59-3c425abd766a4
311994nitrofurantoin macrocrystals 25 MG Oral CapsuleSYcfa20cfd-478f-48c6-9b59-3c425abd766a4
311995nitrofurantoin macrocrystals 50 MG Oral CapsuleSYcfa20cfd-478f-48c6-9b59-3c425abd766a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-603-0068001060300100 CAPSULE in 1 BOTTLE (68001-603-00) 100 capsule2023-10-11NoNoCurrent