Prescription drug · ANDA

Ceftriaxone Sodium NDC 0781-3208

Ceftriaxone sodium 1 g/1 · Injection, Powder, For solution · Intramuscular, Intravenous · Sandoz Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3208Add 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
0781-3208-8500781320885007813208851 VIAL, SINGLE-USE in 1 CARTON (0781-3208-85) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from May 9, 2005
0781-3208-95007813208950078132089510 VIAL, SINGLE-USE in 1 CARTON (0781-3208-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from May 9, 2005

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)
Ceftriaxone Sodium
Generic name (nonproprietary)
ceftriaxone sodium
Active ingredients
Ceftriaxone sodium — 1 g/1
Dosage form
Injection, Powder, For solution
Route
Intramuscular, Intravenous
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065169
Marketing start
Listing expires
Other FDA classes
Cephalosporins (Chemical structure)
Identifiers
Product ID 0781-3208_371d8db2-5d67-4339-92b7-aee2a52b2293SPL ID 371d8db2-5d67-4339-92b7-aee2a52b2293SPL set ID de028434-46cf-44f6-8ac6-889c7c6943b3RxCUI 309092, 1665005, 1665021, 1665046UNII 023Z5BR09K
Pharmacologic class
Cephalosporin Antibacterial

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 codeMed-Code curated

J0696 — Injection, ceftriaxone sodium, per 250 mg

Billing unit: 250 mg. Units on the claim = dose given ÷ 250 mg.

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

N400781320885 followed by a unit qualifier and the quantity

Package 00781-3208-85. 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)

INDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modif…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3208

What is NDC 0781-3208?
0781-3208 is the product NDC for Ceftriaxone Sodium, Ceftriaxone sodium 1 g/1 injection, powder, for solution, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ceftriaxone Sodium.
What is the active ingredient?
Ceftriaxone sodium.
Who is the labeler?
Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ceftriaxone Sodium?
40 other product NDCs are listed under this name. See all Ceftriaxone Sodium NDCs.
Is there a related HCPCS / J-code?
Yes: J0696, Injection, ceftriaxone sodium, per 250 mg. See Billing references above.

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

Other Ceftriaxone Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousREMEDYREPACK INC.70518-249970518-2499-00
Ceftriaxone SodiumCeftriaxone sodium 10 g/1Injection, Powder, For solutionIntravenousApotex Corp.60505-615060505-6150-05
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousSportpharm LLC85766-06985766-0069-0185766-0069-10
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousSportpharm LLC85766-12885766-0128-0185766-0128-10
Ceftriaxone SodiumCeftriaxone sodium 2 g/1Injection, Powder, For solutionIntramuscular, IntravenousApotex Corp.60505-614960505-6149-04
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousApotex Corp.60505-614860505-6148-0060505-6148-04
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousApotex Corp.60505-615160505-6151-0160505-6151-04
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousApotex Corp.60505-615260505-6152-0160505-6152-04
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousProficient Rx LP71205-54571205-0545-01
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousAsclemed USA, Inc.76420-59676420-0596-0176420-0596-10

All 41 Ceftriaxone Sodium NDCs

Other NDCs under ANDA 065169

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

FDA NDC Directory listings under ANDA 065169
ProductStrengthForm · routeLabelerProduct NDC
Ceftriaxone SodiumCeftriaxone sodium 2 g/1Injection, Powder, For solutionIntramuscular, IntravenousProficient Rx LP71205-710
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousSandoz Inc0781-3206
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousSandoz Inc0781-3207
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7332
Ceftriaxone SodiumCeftriaxone sodium 2 g/1Injection, Powder, For solutionIntramuscular, IntravenousSandoz Inc0781-3209
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7332
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousA-S Medication Solutions50090-1875
Ceftriaxone SodiumCeftriaxone sodium 2 g/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7335
Ceftriaxone SodiumCeftriaxone sodium 2 g/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7335
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousSportpharm LLC85766-209
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousSportpharm LLC85766-208
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousSportpharm LLC85766-210
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousA-S Medication Solutions50090-0944
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7337
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7337
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7338
Ceftriaxone SodiumCeftriaxone sodium 500 mg/1Injection, Powder, For solutionIntramuscular, IntravenousHospira, Inc0409-7338
Ceftriaxone SodiumCeftriaxone sodium 250 mg/1Injection, Powder, For solutionIntramuscular, IntravenousA-S Medication Solutions50090-2444
Ceftriaxone SodiumCeftriaxone sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousREMEDYREPACK INC.70518-2499

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