FDA.reportPublic FDA data

NDC 70954-417-10 - L-Glutamine

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
70954-417
Requested NDC
70954-417-10
Package NDCs from labels
70954-417-10, 70954-417-20
Manufacturer
ANI Pharmaceuticals, Inc. | Novitium Pharma LLC
Effective date
2025-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
L-Glutamine - ANI Pharmaceuticals, Inc. | Novitium Pharma LLCANI Pharmaceuticals, Inc. | Novitium Pharma LLC2025-08-07Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-417-10L-Glutamine1 in 1 PACKETPOWDER, FOR SOLUTION12
70954-417-20L-Glutamine60 in 1 CARTONPOWDER, FOR SOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-417L-GLUTAMINE POWDER, FOR SOLUTION [ANI PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240712_bb4ec712-14b7-47e3-8cb9-c71922712e55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-417-10EA - Each70954-4170d8f400b-5ea1-4444-a293-202a2a1c524a12024-08-12
70954-417-20EA - Each70954-417bece2a34-1f27-488e-a842-0830da06895812024-08-12

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 ยท 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 0RH81L854J
L-glutamineL-GLUTAMINECamber Pharmaceuticals, Inc.4d99b233-992f-4adb-aaab-ef0021a3807f2026-06-10Adverse reactionsExact identifier
rxcui: 1869684
unii: 0RH81L854J
L-glutamineL-GLUTAMINERenova Pharmaceuticals LLC3f324755-159b-40ee-a9f4-e6800558acf32026-05-27Adverse reactionsExact identifier
rxcui: 1869684
unii: 0RH81L854J
AKSO N2 Youth Complex EssenceARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, DIOSCOREA VILLOSA, TYROSINEHEALWAY5028304b-22b4-c191-e063-6394a90a55252026-04-23WarningsExact identifier
unii: 0RH81L854J
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: 0RH81L854J
Growth Hormone Drops 2160GROWTH HORMONE DROPSProfessional Complementary Health Formulas56536a40-febe-4856-8a74-ed96a7e5a5c32026-01-08WarningsExact identifier
unii: 0RH81L854J
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 0RH81L854J
L-Glutamine High 7406L-GLUTAMINE HIGHProfessional Complementary Health Formulasad5728b6-d9de-4eac-8a2f-923ddf983c7d2026-01-08WarningsExact identifier
unii: 0RH81L854J
Uric Acid Combination 9307URIC ACID COMBINATIONProfessional Complementary Health Formulas3f136f86-a9ed-4a04-98cb-81abe33cd1812026-01-08WarningsExact identifier
unii: 0RH81L854J
L-GlutamineL-GLUTAMINEANI Pharmaceuticals, Inc.bb4ec712-14b7-47e3-8cb9-c71922712e552025-08-07Adverse reactionsExact identifier
application number: ANDA215647
ndc (package): 70954-417-10
ndc (package): 70954-417-20
ndc (product): 70954-417
ndc11 (package): 70954041710
rxcui: 1869684
spl id: 0635706e-180e-435e-92cf-c85e0ca4f7e0
spl set id: bb4ec712-14b7-47e3-8cb9-c71922712e55
unii: 0RH81L854J
EndariGLUTAMINEEmmaus Medical, Inc.d5a783f4-12ef-4326-8faa-40018e45ba3b2025-06-20Adverse reactionsExact identifier
rxcui: 1869684
unii: 0RH81L854J
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.8ca76872-a187-4fd8-8daf-9ee351bdf3462025-01-28WarningsExact identifier
unii: 0RH81L854J
D-76LOBELIA INFLATA, STRYCHNOS IGNATII SEED, AVENA SATIVA FLOWERING TOP, DIBASIC POTASSIUM PHOSPHATE, SELENICEREUS GRANDIFLORUS STEM, GLUTAMINE, TAURINE, AND THIAMINE HYDROCHLORIDEDNA Labs, Inc.ea7aadf5-0ee2-4b0a-9ba8-0a5d98944bd12025-01-13WarningsExact identifier
unii: 0RH81L854J
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 0RH81L854J
RecovatoneGLYCYRRHIZA GLABRA, KALI MURIATICUM, KALI PHOSPHORICUM, IODIUM, ZINCUM GLUCONICUM, PHOSPHORUS, ASCORBICUM ACIDUM, CALCIUM GLUCONATE, L-ARGININE, L-CARNITINE, L-ORNITHINE, MAGNESIA MURIATICA, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NATRUM MURIATICUM, COBALT GLUCONATE, COPPER GLUCONATE, CREATINE, L-GLUTAMINE, L-LEUCINE, L-VALINE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, ADRENALINUM, BORON, CALCAREA PHOSPHORICA, FERRUM SULPHURICUM, MOLYBDENUM, NICCOLUM METALLICUM, SELENIUM METALLICUM,Energique, Inc.38fd4f98-a42a-435b-9643-16df664539512024-10-29WarningsExact identifier
unii: 0RH81L854J
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 0RH81L854J
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 0RH81L854J
HGH COMPLEXARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, LYSINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, TRIBULUS TERRESTRIS, TYROSINE, CDP-CHOLINE, GABAProBlen2b7ee28f-474e-414b-bf74-8b2baf3829472022-11-30WarningsExact identifier
unii: 0RH81L854J

Reported adverse events (FAERS/openFDA)#

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