NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3481Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3481Add 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
0781-3481-92007813481920078134819210 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)Marketed from Nov 30, 2017

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)
Tigecycline
Generic name (nonproprietary)
tigecycline
Active ingredients
Tigecycline — 50 mg/10mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous, Parenteral
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091620
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 0781-3481_c5721224-91db-4fe4-b746-139bce5ff19cSPL ID c5721224-91db-4fe4-b746-139bce5ff19cSPL set ID 50605463-2dc2-4b27-bc51-4d87bb9a8539RxCUI 581531UNII 70JE2N95KR
Pharmacologic class
Tetracycline-class 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 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

N400781348192 followed by a unit qualifier and the quantity

Package 00781-3481-92. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • Complicated skin and skin structure infections ( 1.1 ) • Complicated intra-abdominal infections ( 1.2 ) • Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for injection and other antibacterial drugs, Tigecycline for injection should be used only to treat infections that are proven or strongly sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3481

What is NDC 0781-3481?
0781-3481 is the product NDC for Tigecycline, Tigecycline 50 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tigecycline.
What is the active ingredient?
Tigecycline.
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 Tigecycline?
4 other product NDCs are listed under this name. See all Tigecycline 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 Tigecycline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TigecyclineTigecycline 50 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousMeitheal Pharmaceuticals Inc.71288-01971288-0019-11
TigecyclineTigecycline 50 mg/1Injection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-22855150-0228-10
TigecyclineTigecycline 50 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousApotex Corp60505-609860505-6098-01
TigecyclineTigecycline 50 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousAmneal Pharmaceuticals LLC70121-164770121-1647-07

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