FDA.reportPublic FDA data

NDC 59762-1005-01 - Cabergoline

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
59762-1005
Requested NDC
59762-1005-01
Package NDCs from labels
59762-1005-1, 59762-1005-01
Manufacturer
Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Italia S.r.l.
Effective date
2026-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cabergoline - Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Italia S.r.l.Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Italia S.r.l.2026-06-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1005-1Cabergoline8 in 1 BOTTLETABLET811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1005CABERGOLINE TABLET [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20250528_e497366b-a124-4d7f-bd45-a883c392d4bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1005-1EA - Each59762-10050d2a8657-0319-491c-b79b-78ca8765853912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CABERGOLINEACTIVE INGREDIENTLL60K9J05TCABERGOLINE TABLET [GREENSTONE LLC]3
CABERGOLINEACTIVE MOIETYLL60K9J05TCABERGOLINE TABLET [GREENSTONE LLC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCABERGOLINE TABLET [GREENSTONE LLC]3
LEUCINEINACTIVE INGREDIENTGMW67QNF9CCABERGOLINE TABLET [GREENSTONE LLC]3

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: GMW67QNF9C
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
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: GMW67QNF9C
CabergolineCABERGOLINEMylan Pharmaceuticals Inc.e497366b-a124-4d7f-bd45-a883c392d4bb2026-06-30Warnings, Adverse reactionsExact identifier
application number: NDA020664
ndc (package): 59762-1005-1
ndc (product): 59762-1005
ndc11 (package): 59762100501
rxcui: 199703
spl id: 03f16695-e1cd-4d6b-9205-b3d5bf1b7c6c
spl set id: e497366b-a124-4d7f-bd45-a883c392d4bb
unii: LL60K9J05T
CABERGOLINECABERGOLINECranbury Pharmaceuticals, LLC8562f94f-a59a-4893-aefc-ea6547b01e922026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
CabergolineCABERGOLINEA-S Medication Solutionsc9f0b576-d5e5-4e3e-bb5c-3574d75d99072026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T
L-Leucine High 7414L-LEUCINE HIGHProfessional Complementary Health Formulas261acb1f-4767-4ac9-92ba-8f3f60b57b922026-01-08WarningsExact identifier
unii: GMW67QNF9C
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G
CabergolineCABERGOLINESOLA Pharmaceuticals, LLC275a6a25-c3c9-4258-a610-0b00752517f72025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: GMW67QNF9C
CabergolineCABERGOLINEA-S Medication Solutions9405c116-4a77-4e14-9ab8-25e899595cdf2025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: J2B2A4N98G
CabergolineCABERGOLINEIngenus Pharmaceuticals, LLC57cbd81e-fdb9-4060-80ee-6e8581c463a42025-07-04Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T
CabergolineCABERGOLINETeva Pharmaceuticals USA, Inc.74b61e8a-7ae9-4996-85ec-df23c56de16f2025-06-16Warnings, Adverse reactionsExact identifier
rxcui: 199703
unii: LL60K9J05T

Reported adverse events (FAERS/openFDA)#

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