Prescription drug · NDA
Xerava (Eravacycline) NDC 71773-100
Eravacycline dihydrochloride 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Tetraphase Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71773-100-12 | 71773010012 | 12 CARTON in 1 PACKAGE (71773-100-12) / 1 VIAL, GLASS in 1 CARTON (71773-100-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from Sep 14, 2020 |
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)
- Xerava
- Generic name (nonproprietary)
- eravacycline
- Active ingredients
- Eravacycline dihydrochloride — 100 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Tetraphase Pharmaceuticals, Inc.NDC labeler code 71773
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211109
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 71773-100_a3d105c1-c9b1-42ce-942d-34e63fdf5d83SPL ID a3d105c1-c9b1-42ce-942d-34e63fdf5d83SPL set ID a4b188d4-f467-470c-ad7b-25ffbdd8862aRxCUI 2055911, 2055916, 2374556, 2374558UNII WK1NMH89VJUPC 0371773100052
- 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.
- NDC on a medical claim
N471773010012followed by a unit qualifier and the quantityPackage 71773-0100-12. 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)
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. ( 1.1 ) Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.2 ) 1.1 Complicated Intra-abdominal Infections XERAVA is indicated for the treatment of complicated intra‑abdominal infections (cIAI) caused by susceptible mi…
Excerpt only. Read the full label for complete information.
About NDC 71773-100
- What is NDC 71773-100?
- 71773-100 is the product NDC for Xerava (eravacycline), Eravacycline dihydrochloride 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Tetraphase Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xerava (Eravacycline).
- What is the active ingredient?
- Eravacycline dihydrochloride.
- Who is the labeler?
- Tetraphase Pharmaceuticals, Inc., NDC labeler code 71773. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xerava?
- 1 other product NDC are listed under this name. See all Xerava NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xerava products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xeravaeravacycline | Eravacycline dihydrochloride 50 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Tetraphase Pharmaceuticals, Inc. | 71773-050 | 71773-0050-0571773-0050-12 |
Other NDCs under NDA 211109
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xeravaeravacycline | Eravacycline dihydrochloride 50 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Tetraphase Pharmaceuticals, Inc. | 71773-050 |