FDA.reportPublic FDA data

NDC 0409-7875-01 - Precedex

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
0409-7875
Requested NDC
0409-7875-01
Package NDCs from labels
0409-7875-01, 0409-7875-12
Manufacturer
Hospira, Inc. | Pfizer Healthcare India Private Limited
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Precedex - Hospira, Inc. | Pfizer Healthcare India Private LimitedHospira, Inc. | Pfizer Healthcare India Private Limited2026-05-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7875-01Precedex250 mL in 1 BAGINJECTION, SOLUTION25059
0409-7875-12Precedex12 in 1 CASEINJECTION, SOLUTION1259
0409-7875-12Precedex1 in 1 POUCHINJECTION, SOLUTION159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7875PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]53Current NDC, 3 package rows20250326_548a88c0-afda-427e-75ac-5af0cfa2224c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7875-01ML - Milliliter0409-78756db07eeb-f304-4c80-a459-e1818c8eb2e612025-05-14
0409-7875-12ML - Milliliter0409-7875e8733e4a-4f72-40c0-9f16-2f89b4420bcf12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONOPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27
WATERINACTIVE INGREDIENT059QF0KO0RPRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]27

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 6 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PRECEDEXDEXMEDETOMIDINE HYDROCHLORIDEHenry Schein, Inc.9eb336de-5fa5-4b46-b40b-a7ca5a0864bd2026-05-21Warnings, Adverse reactionsExact identifier
application number: NDA021038
rxcui: 309710
rxcui: 284397
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEGland Pharma Limitedf307de7e-a9ab-4734-abb7-66b4e112bc512026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 1718906
rxcui: 1718909
unii: 1018WH7F9I
PrecedexDEXMEDETOMIDINE HYDROCHLORIDEHospira, Inc.548a88c0-afda-427e-75ac-5af0cfa2224c2026-05-20Warnings, Adverse reactionsExact identifier
application number: NDA021038
ndc (package): 0409-7853-24
ndc (package): 0409-1596-01
ndc (package): 0409-1638-32
ndc (package): 0409-1434-01
ndc (package): 0409-1660-50
ndc (package): 0409-7875-01
ndc (package): 0409-1660-22
ndc (package): 0409-1660-35
ndc (package): 0409-7853-01
ndc (package): 0409-1660-20
ndc (package): 0409-7838-24
ndc (package): 0409-7875-12
ndc (package): 0409-1660-10
ndc (package): 0409-1596-10
ndc (package): 0409-1660-55
ndc (package): 0409-7838-01
ndc (package): 0409-1638-02
ndc (product): 0409-1660
ndc (product): 0409-7838
ndc (product): 0409-7853
ndc (product): 0409-1638
ndc (product): 0409-1434
ndc (product): 0409-7875
ndc (product): 0409-1596
ndc11 (package): 00409787501
rxcui: 309710
rxcui: 2396891
rxcui: 284397
rxcui: 1718910
rxcui: 1718907
rxcui: 1718906
rxcui: 1718909
rxcui: 2396892
rxcui: 1718900
rxcui: 1718902
spl id: 3c5274fd-6597-4b88-babc-92e4e16c6329
spl set id: 548a88c0-afda-427e-75ac-5af0cfa2224c
unii: 1018WH7F9I
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEMylan Institutional LLCf140de5a-f13d-46b4-a742-049c63e474f52026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 1718906
rxcui: 1718909
unii: 1018WH7F9I
Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDEAmneal Pharmaceuticals LLC4df8cc35-fc80-4438-b982-9c4b7d17bad22026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 1718906
rxcui: 1718909
unii: 1018WH7F9I
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DexmedetomidineDEXMEDETOMIDINEGland Pharma Limited714cc0d2-8a4c-40c0-8ef0-dcfde4c469892026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
DexmedetomidineDEXMEDETOMIDINEMylan Institutional LLCebdfe2e8-30ca-4f18-935a-41bcbbce49372026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 309710
unii: 1018WH7F9I
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
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
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
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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