Prescription drug · NDA

Dextrose (Dextrose monohydrate) NDC 0338-0078

Dextrose monohydrate 5 g/100mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)0338-0078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-0078Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0338-0078-200033800782020 BAG in 1 CARTON (0338-0078-20) / 500 mL in 1 BAGMarketed from Mar 6, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Dextrose
Generic name (nonproprietary)
dextrose monohydrate
Active ingredients
Dextrose monohydrate — 5 g/100mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Baxter Healthcare CorporationNDC labeler code 0338
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 016673
Marketing start
Listing expires
Identifiers
Product ID 0338-0078_b28d6bb9-8496-48bd-b6aa-f67996d0829cSPL ID b28d6bb9-8496-48bd-b6aa-f67996d0829cSPL set ID 36e9478c-5df0-4b47-b97d-de3626d7cb29RxCUI 1795607, 1795609, 1795610, 1795612, 1795616UNII LX22YL083G

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400338007820 followed by a unit qualifier and the quantity

Package 00338-0078-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-0078

What is NDC 0338-0078?
0338-0078 is the product NDC for Dextrose (dextrose monohydrate), Dextrose monohydrate 5 g/100mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dextrose (Dextrose monohydrate).
What is the active ingredient?
Dextrose monohydrate.
Who is the labeler?
Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dextrose?
69 other product NDCs are listed under this name. See all Dextrose NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dextrose NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dextrosedextrose monohydrateDextrose monohydrate 250 mg/mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-445270518-4452-00
Dextrosedextrose monohydrateDextrose monohydrate 25 g/50mLInjection, SolutionIntravenousREMEDYREPACK INC.70518-421970518-4219-00
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousProPharma Distribution84549-46084549-0460-20
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousFRESENIUS KABI USA, LLC65219-45865219-0458-30
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousFRESENIUS KABI USA, LLC65219-45665219-0456-60
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousFRESENIUS KABI USA, LLC65219-46265219-0462-10
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousFRESENIUS KABI USA, LLC65219-46065219-0460-20
Dextrosedextrose monohydrateDextrose monohydrate 50 mg/mLInjection, SolutionIntravenousFRESENIUS KABI USA, LLC65219-46465219-0464-50
Dextrosedextrose monohydrateDextrose monohydrate 25 g/50mLInjection, SolutionIntravenousHenry Schein, Inc.0404-984500404-9845-50
Dextrosedextrose monohydrateDextrose monohydrate 25 g/50mLInjection, SolutionIntravenousHenry Schein, Inc.0404-984700404-9847-50

All 70 Dextrose NDCs

Other NDCs under NDA 016673

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016673
ProductStrengthForm · routeLabelerProduct NDC
Dextrosedextrose monohydrateDextrose monohydrate 2.5 g/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9649
Dextrosedextrose monohydrateDextrose monohydrate 2.5 g/50mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9651
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9653
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0062
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9655
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0066
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0070
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0074
Dextrosedextrose monohydrateDextrose monohydrate 50 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0017
Dextrosedextrose monohydrateDextrose monohydrate 5 g/100mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0082

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