NDC 51688-9397 - 49662-25 SPINAL 25G PENCIL POINT

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
51688-9397
Package NDCs from labels
51688-9397-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.
Effective date
2016-08-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Epinephrine - Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc.2016-08-02MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT849662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BH49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X449662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098749662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OK49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C49662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7449662-25 SPINAL 25G PENCIL POINT () C47916 [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0R49662-25 SPINAL 25G PENCIL POINT () C47916 [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 88 of 116 · 2,312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst8c63be55-5de4-7f72-e053-2995a90a102e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst99516811-56e2-9c8a-e053-2a95a90ac9cb2024-01-30Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst946ce625-3647-5083-e053-2a95a90a1ebc2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstc0d1def8-9f47-0d3e-e053-2995a90af9552024-01-30Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999dd95d-87fe-12c0-e053-2995a90aa9f72024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1010033
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4bf5905-add7-1cb0-e053-2995a90a73342024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4c0df51-cc37-323d-e053-2995a90a154a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals7a664a34-19fd-4a7b-ab4d-11299b32999e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticalsfd6343a9-15a6-4894-b51f-122e4d6dbe792024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESeton Pharmaceuticals1c0abe84-5404-404e-b882-e910e4d43ffb2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals951862db-3a73-4d25-9d5b-e4111833f43b2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals6aa284d6-0212-4fb5-809d-c721aa6fe2ba2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst993bc59e-5e71-bd9e-e053-2a95a90af85c2024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1010671
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirstc4c16714-6b1f-857e-e053-2a95a90a74e42024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirste3b3b462-8f35-68b8-e053-2995a90a64032024-01-27Warnings, Adverse reactionsExact identifier
rxcui: 1010033
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8bc96bc-7876-4906-e053-2a95a90ae6ba2024-01-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA080408
rxcui: 1737568
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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