FDA.reportPublic FDA data

NDC 70385-2033-01 - Naloxone Hydrochloride

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
70385-2033
Requested NDC
70385-2033-01
Package NDCs from labels
70385-2033-1, 70385-2033-01
Manufacturer
Sina Health Inc
Effective date
2026-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naloxone Hydrochloride - Sina Health IncSina Health Inc2026-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70385-2033-1Naloxone Hydrochloride1 in 1 PACKAGEINJECTION, SOLUTION111
70385-2033-1Naloxone Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2033NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SINA HEALTH INC]10Current NDC, 2 package rows20241207_2879294f-9af9-459e-e063-6394a90a0820.zip

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 44 of 54 · 1,075 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: 451W47IQ8X
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: 451W47IQ8X
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHospira, Inc.b598c237-032d-4bb5-0e92-50eabd863dac2023-06-04Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEA-S Medication Solutions3d2dcee4-7510-477b-95a8-9b2afb7739842023-05-23Warnings, Adverse reactionsExact identifier
rxcui: 1659929
unii: F850569PQR
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC958577c3-d2c4-26ad-e053-2a95a90ad73a2023-05-15Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC9e53f169-4a6e-6102-e053-2995a90ab3dc2023-05-09Warnings, Adverse reactionsExact identifier
application number: ANDA207633
rxcui: 1659929
unii: F850569PQR
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6856c-5293-fc2f-e053-2995a90a8ec62023-05-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCb621239f-0bbb-7d07-e053-2a95a90a287e2023-04-26Warnings, Adverse reactionsExact identifier
rxcui: 1659929
unii: F850569PQR
Naloxone HydrochlorideNALXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC8959171f-eda6-158c-e053-2995a90a36b22023-04-26Warnings, Adverse reactionsExact identifier
rxcui: 1659929
unii: F850569PQR
naloxone hydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCfa1ca55b-f56b-0d9b-e053-6294a90a258a2023-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1659929
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCea4ea2fe-af48-0b3c-e053-2a95a90a0ad52023-04-24Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCf9c5efca-443a-41a0-e053-6294a90a87742023-04-20Warnings, Adverse reactionsExact identifier
unii: F850569PQR
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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