FDA.reportPublic FDA data

NDC 0409-5010-01 - Marcaine

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
0409-5010
Requested NDC
0409-5010-01
Package NDCs from labels
0409-5010-01, 0409-5010-25
Manufacturer
Henry Schein, Inc.
Effective date
2026-06-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Marcaine - Henry Schein, Inc.Henry Schein, Inc.2026-06-24HUMAN PRESCRIPTION DRUG LABEL
Marcaine - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-05-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-5010-01Marcaine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1037
0409-5010-25Marcaine25 in 1 TRAYINJECTION, SOLUTION2537

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-5010MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]33Current NDC, 2 package rows20250529_67578b56-7540-487e-1fba-481255620e78.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-5010-01ML - Milliliter0409-5010a316b0f7-5e83-4479-9acd-55c2962a5c8612025-03-04
0409-5010-25ML - Milliliter0409-5010bb1b4573-3d2e-4637-be39-f65591e8acac12025-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
BUPIVACAINEACTIVE MOIETYY8335394ROMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13

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 7 of 69 · 1,380 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
VitaluxMULTIVITAMINPureTek Corporation52d5eee7-8146-cc62-e063-6394a90a8c3f2026-06-02Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA016964
ndc (package): 0409-5010-01
ndc (package): 0409-1559-19
ndc (package): 0409-1746-71
ndc (package): 0409-1560-18
ndc (package): 0409-1749-70
ndc (package): 0409-1559-10
ndc (package): 0409-7535-01
ndc (package): 0409-1746-30
ndc (package): 0409-0525-25
ndc (package): 0409-1746-70
ndc (package): 0409-1559-18
ndc (package): 0409-1582-10
ndc (package): 0409-1250-01
ndc (package): 0409-2253-01
ndc (package): 0409-1582-18
ndc (package): 0409-1749-10
ndc (package): 0409-1530-25
ndc (package): 0409-1755-50
ndc (package): 0409-1587-50
ndc (package): 0409-1560-19
ndc (package): 0409-1610-50
ndc (package): 0409-1749-29
ndc (package): 0409-5010-25
ndc (package): 0409-1250-25
ndc (package): 0409-0525-01
ndc (package): 0409-7535-25
ndc (package): 0409-1560-29
ndc (package): 0409-1582-29
ndc (package): 0409-1559-30
ndc (package): 0409-1749-71
ndc (package): 0409-1560-10
ndc (package): 0409-2253-25
ndc (package): 0409-2510-25
ndc (package): 0409-7510-01
ndc (package): 0409-1746-10
ndc (package): 0409-1582-19
ndc (package): 0409-1530-01
ndc (package): 0409-2510-01
ndc (package): 0409-1752-50
ndc (package): 0409-7510-25
ndc (product): 0409-1559
ndc (product): 0409-1530
ndc (product): 0409-7510
ndc (product): 0409-1560
ndc (product): 0409-1250
ndc (product): 0409-0525
ndc (product): 0409-1752
ndc (product): 0409-1610
ndc (product): 0409-1582
ndc (product): 0409-7535
ndc (product): 0409-5010
ndc (product): 0409-1755
ndc (product): 0409-1749
ndc (product): 0409-2510
ndc (product): 0409-1746
ndc (product): 0409-1587
ndc (product): 0409-2253
ndc11 (package): 00409501001
rxcui: 1673243
rxcui: 1724880
rxcui: 1724884
rxcui: 1012384
rxcui: 1012404
rxcui: 1672919
rxcui: 1724787
rxcui: 1725046
rxcui: 1012388
rxcui: 1867612
rxcui: 1012381
rxcui: 1012406
rxcui: 1867596
rxcui: 1724794
rxcui: 1725078
rxcui: 1012377
rxcui: 1725044
rxcui: 1012400
rxcui: 1725082
rxcui: 1867614
rxcui: 1673242
rxcui: 1012396
rxcui: 1725083
rxcui: 1724796
rxcui: 1725079
rxcui: 1672917
rxcui: 1867594
rxcui: 1724786
spl id: 7040888c-2cde-4408-af99-d249985f8444
spl set id: 67578b56-7540-487e-1fba-481255620e78
unii: 30Q7KI53AK
unii: 7TQO7W3VT8
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: PQ6CK8PD0R
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Norixa MiniNORIXA MINIFlorrax Pharmaceutical0aba2b6f-50b2-48c1-992b-d481b5394d532026-05-11Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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