FDA.reportPublic FDA data

NDC 51688-8648 - A2487-18 PORTEX SINGLE SHOT EPIDURAL

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
51688-8648
Package NDCs from labels
51688-8648-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.
Effective date
2012-11-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
A2487-18 PORTEX SINGLE SHOT EPIDURALSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.2012-11-29MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394ROA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, 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 24 of 72 · 1,438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED5c10e3a1-7806-40c7-afd2-4c420e1418232025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED02d0e5f1-5fab-4420-b673-785fd81d7ae22025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
PVP-Iodine Swabstick ThreesPOVIDONE-IODINEDukal LLC5af20b49-11b1-4b15-bb7f-eccda2c469972025-11-19WarningsExact identifier
unii: 85H0HZU99M
PVP-I Pouch foil-foilPOVIDONE-IODINEDukal LLC45aefabf-5283-411a-b509-7499776359382025-11-19WarningsExact identifier
unii: 85H0HZU99M
PVP-I Prep Pads foil-foilPOVIDONE-IODINEDukal LLC95c35c0d-bebb-46d0-8e97-f3d2541723ad2025-11-19WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine GelPOVIDONE-IODINEDukal LLC2bebe082-59b6-17c1-e063-6294a90a9a522025-11-19WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Gel SwabstickPOVIDONE IODINEDukal LLC98be29e6-0c9b-22a6-e053-2995a90a9f8c2025-11-19WarningsExact identifier
unii: 85H0HZU99M
Dukal Povidone-Iodine Scrub Winged SpongesPOVIDONE-IODINE SCRUB WINGED SPONGESDukal LLCe8bce905-929e-30e4-e053-2a95a90a909f2025-11-19WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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