FDA.reportPublic FDA data

NDC 0093-7865-19 - Fentanyl Citrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0093-7865
Requested NDC
0093-7865-19
Package NDCs from labels
0093-7865-19, 0093-7865-65
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2026-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fentanyl Citrate - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2026-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7865-19Fentanyl Citrate1 in 1 BLISTER PACKLOZENGE116
0093-7865-65Fentanyl Citrate30 in 1 CARTONLOZENGE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7865FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA, INC.]15Legacy NDC, 2 package rows20241018_78221eab-66fd-4cd8-9c81-af52eb83671c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7865-19EA - Each0093-7865167fb4ff-f7f3-4fa7-9cae-dca38b3602d312015-12-02
0093-7865-65EA - Each0093-786576aa8ab8-e9a9-4f34-960c-22261c534e1d12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYL CITRATEACTIVE INGREDIENTMUN5LYG46HFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
FENTANYLACTIVE MOIETYUF599785JZFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
DEXTRATESINACTIVE INGREDIENTG263MI44RUFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FFENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554FENTANYL CITRATE LOZENGE [TEVA PHARMACEUTICALS USA INC]1

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 2 of 9 · 174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 22ADO53M6F
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.ce5db1c2-feb1-4ad2-847a-d02e865bd47e2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
4dbe9184-14cd-4666-aabf-1b7fece9233778221eab-66fd-4cd8-9c81-af52eb83671c2026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 4dbe9184-14cd-4666-aabf-1b7fece92337
spl set id: 78221eab-66fd-4cd8-9c81-af52eb83671c
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
Fentanyl CitrateFENTANYL CITRATECivica, Inc.aacf276b-e133-4199-ad3f-67b894744c042025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATEPhlow Corp.58dcd3f7-e3d8-4929-a186-8f680a51ff112025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b72025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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