FDA.reportPublic FDA data

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Product NDC
82619-147
11-digit product format
826190147
Labeler code
82619
Product ID
82619-147_4f67eeb9-5a7a-3693-e063-6394a90a8655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA220269
Marketing category
ANDA
Marketing start
2026-04-20
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], 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 43.

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
A220269-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORALAB2026-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220269-001AB

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
2026-09-14 22:38:342026-08A220269-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07A220269-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2026-04-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220269-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2026-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220269-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220269-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220269-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN25 mg/1
NITROFURANTOIN MONOHYDRATE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
927AH8112LInternal UNII lookup
E1QI2CQQ1IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648755Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e47175a3-68a2-4084-9c0e-96fb057448bfAvailable 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
82619-147-01NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)100 in 1 BOTTLECAPSULE1001
82619-147-02NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)500 in 1 BOTTLECAPSULE5001
82619-147-03NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)14 in 1 BLISTER PACKCAPSULE141
82619-147-03NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)1 in 1 CARTONCAPSULE11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Creekwood Pharmaceuticals LLCe47175a3-68a2-4084-9c0e-96fb057448bf2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220269
application number: ANDA220269
ndc (product): 82619-147

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNe47175a3-68a2-4084-9c0e-96fb057448bf1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDe47175a3-68a2-4084-9c0e-96fb057448bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-147-0182619014701100 CAPSULE in 1 BOTTLE (82619-147-01) 100 capsule2026-04-20NoNoCurrent
82619-147-0282619014702500 CAPSULE in 1 BOTTLE (82619-147-02) 500 capsule2026-04-20NoNoCurrent
82619-147-03826190147031 BLISTER PACK in 1 CARTON (82619-147-03) / 14 CAPSULE in 1 BLISTER PACK1 blister pack2026-04-20NoNoCurrent