Prescription drug · ANDA

Sodium Chloride NDC 76297-001

Sodium chloride 9 g/1000mL · Injection, Solution · Intravenous · LABORATORIOS GRIFOLS SA

NDC codes

FDA NDC Directory
Product NDC (as listed)76297-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76297-0001Add 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
76297-001-01762970001017629700010120 BAG in 1 CARTON (76297-001-01) / 500 mL in 1 BAG (76297-001-02)Marketed from May 25, 2017
76297-001-117629700011176297000111115 BAG in 1 CARTON (76297-001-11) / 50 mL in 1 BAG (76297-001-12)Marketed from Dec 1, 2018
76297-001-21762970001217629700012170 BAG in 1 CARTON (76297-001-21) / 100 mL in 1 BAG (76297-001-22)Marketed from Dec 1, 2018
76297-001-31762970001317629700013128 BAG in 1 CARTON (76297-001-31) / 250 mL in 1 BAG (76297-001-32)Marketed from Dec 1, 2018
76297-001-41762970001417629700014110 BAG in 1 CARTON (76297-001-41) / 1000 mL in 1 BAG (76297-001-42)Marketed from Mar 1, 2019
76297-001-51762970001517629700015190 BAG in 1 CARTON (76297-001-51) / 50 mL in 1 BAG (76297-001-52)Marketed from Aug 6, 2022
76297-001-61762970001617629700016150 BAG in 1 CARTON (76297-001-61) / 100 mL in 1 BAG (76297-001-62)Marketed from Aug 6, 2022
76297-001-71762970001717629700017132 BAG in 1 CARTON (76297-001-71) / 250 mL in 1 BAG (76297-001-72)Marketed from Aug 6, 2022
76297-001-81762970001817629700018124 BAG in 1 CARTON (76297-001-81) / 500 mL in 1 BAG (76297-001-82)Marketed from Aug 6, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Sodium Chloride
Generic name (nonproprietary)
sodium chloride
Active ingredients
Sodium chloride — 9 g/1000mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
LABORATORIOS GRIFOLS SANDC labeler code 76297
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207956
Marketing start
Listing expires
Identifiers
Product ID 76297-001_f563c65c-6c3d-498f-99be-46552453f6ceSPL ID f563c65c-6c3d-498f-99be-46552453f6ce

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

N476297000101 followed by a unit qualifier and the quantity

Package 76297-0001-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 76297-001

What is NDC 76297-001?
76297-001 is the product NDC for Sodium Chloride, Sodium chloride 9 g/1000mL injection, solution, listed with the FDA by LABORATORIOS GRIFOLS SA. It has 9 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sodium Chloride.
What is the active ingredient?
Sodium chloride.
Who is the labeler?
LABORATORIOS GRIFOLS SA, NDC labeler code 76297. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sodium Chloride?
116 other product NDCs are listed under this name. See all Sodium Chloride 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 Sodium Chloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sodium ChlorideSodium chloride 50 mg/gOintmentOphthalmicYYBA CORP73581-70773581-0707-0173581-0707-03
Sodium ChlorideSodium chloride 1 g/1TabletOralMethod Pharmaceuticals, LLC58657-11958657-0119-01
Sodium chlorideSodium chloride .9 g/100mLInjection, SolutionIrrigationFresenius Kabi USA, LLC65219-50265219-0502-10
Sodium chlorideSodium chloride .9 g/100mLInjection, SolutionIrrigationFresenius Kabi USA, LLC65219-50465219-0504-20
Sodium chlorideSodium chloride .9 g/100mLInjection, SolutionIrrigationBecton Dickinson and Company17271-80017271-0800-0717271-0800-0817271-0800-09
Sodium ChlorideSodium chloride 1000 mg/1TabletOralRising Pharma Holdings, Inc.57237-36157237-0361-01
Sodium chlorideSodium chloride .9 g/100mLInjection, SolutionIrrigationFresenius Kabi USA, LLC65219-50665219-0506-30
Sodium Chloridesodium chloride tabletsSodium chloride 1000 mg/1TabletOralKesin Pharma Corporation81033-02881033-0028-01
Sodium Chloridesodium chloride tabletSodium chloride 1000 mg/1TabletOralBelleview Bioscience LLC84447-00284447-0002-01
Sodium ChlorideSodium chloride 900 mg/100mLIrrigantIrrigationBaxter Healthcare Company0338-983400338-9834-04

All 117 Sodium Chloride NDCs

Other NDCs under ANDA 207956

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

FDA NDC Directory listings under ANDA 207956
ProductStrengthForm · routeLabelerProduct NDC
0.9% Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1609
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousSOLA Pharmaceuticals, LLC70512-841
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousNextgen Pharmaceuticals LLC79672-613
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousCODAN US CORPORATION81826-001

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