FDA.reportPublic FDA data

NDC 0338-0081-02

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
0338-0081
Requested NDC
0338-0081-02
Package NDCs from labels
0338-0081-02
Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0081DEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]14Legacy NDC20250519_dcbf1907-1841-4afc-ab5d-a9893a2d7256.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0081-02ML - Milliliter0338-00817a48a503-b965-4622-8a4f-2083b1ad3eb012012-07-24
0338-0081-03ML - Milliliter0338-0081137b187c-f4c9-4379-97ba-32f53e35b1fc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
CHLORIDE IONACTIVE MOIETYQ32ZN48698DEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE AND SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6

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 1 of 17 · 324 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
OXACILLINOXACILLINBaxter Healthcare Corporationd893e45b-7f18-4c67-b10c-1e2e52a6b3ef2026-08-31Warnings, Adverse reactionsName fallback
manufacturer name: Baxter Healthcare Corporation
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsName fallback
generic name: SODIUM CHLORIDE
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsName fallback
brand name: Dextrose and Sodium Chloride
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsName fallback
manufacturer name: Baxter Healthcare Corporation
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
PENICILLIN G POTASSIUMPENICILLIN GBaxter Healthcare Corporation9e58122f-5c75-4905-a774-d3a4dae4ff8c2026-07-24Warnings, Adverse reactionsName fallback
manufacturer name: Baxter Healthcare Corporation
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsName fallback
generic name: DEXTROSE MONOHYDRATE
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsName fallback
generic name: SODIUM CHLORIDE
LEVOCARNITINELEVOCARNITINEBaxter Healthcare Corporation1f38ab0d-ef89-4e92-990f-9da190057e172026-07-02Warnings, Adverse reactionsName fallback
manufacturer name: Baxter Healthcare Corporation
CefepimeCEFEPIMEBaxter Healthcare Corporationbe5f8ca6-7232-423a-a2d5-cccb7abe79212026-06-25Warnings, Adverse reactionsName fallback
manufacturer name: Baxter Healthcare Corporation

Reported adverse events (FAERS/openFDA)#

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