FDA.reportPublic FDA data

NDC 70771-1908-7 - bosentan

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
70771-1908
Requested NDC
70771-1908-7
Package NDCs from labels
70771-1908-7, 70771-1908-8
Manufacturer
Zydus Lifesciences Limited
Effective date
2026-02-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
bosentan - Zydus Lifesciences LimitedZydus Lifesciences Limited2026-02-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1908-7bosentan14 in 1 BLISTER PACKTABLET, FOR SUSPENSION141
70771-1908-8bosentan4 in 1 CARTONTABLET, FOR SUSPENSION41

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 12 of 33 · 642 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Gout Pain ManagementARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFForces of Nature9276fe9c-d9a2-4cef-986c-5d7d39f2d6a12025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo SarcodeTEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHURNutritional Specialties, Inc.c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d2025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Inc.5590d577-3a98-49b8-bb12-ddd7f5cfd0802025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Formica Stibium comp.FORMICA STIBIUM COMP.Uriel Pharmacy Inc.439073f2-1dee-4b4e-a65e-74aee1c73c2b2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Polygonatum CepaPOLYGONATUM CEPAUriel Pharmacy Inc.6ba0ac36-16cc-49bd-b37f-90cf18acbd5a2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
TracleerBOSENTANActelion Pharmaceuticals US, Inc.749e42fb-2fe0-45dd-9268-b43bb3f4081c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1989081
unii: Q326023R30

Reported adverse events (FAERS/openFDA)#

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