NDC codes

FDA NDC Directory
Product NDC (as listed)0008-4990Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00008-4990Add 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
0008-4990-200000849902010 VIAL, SINGLE-DOSE in 1 CARTON (0008-4990-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4990-19)Marketed from Sep 30, 2009

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)
Tygacil
Generic name (nonproprietary)
tigecycline
Active ingredients
Tigecycline50 mg/5mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021821
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95bSPL ID 471458bc-2d5f-470b-a6a4-f4bf0eacf95bSPL set ID 2ccdb48e-c14a-4eeb-348c-4920ccfd7465RxCUI 581531, 584201UNII 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

N400008499020 followed by a unit qualifier and the quantity

Package 00008-4990-20. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

TYGACIL 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 : TYGACIL 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 TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.5 ). 1.1 Complicated Skin and Skin

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021821

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

FDA NDC Directory listings under NDA 021821
ProductStrengthForm · routeLabelerProduct NDC
TygaciltigecyclineTigecycline 50 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.0008-4994

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in