Prescription drug · ANDA
Terbutaline Sulfate NDC 63323-665
Terbutaline sulfate 1 mg/mL · Injection, Solution · Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-665-01 | 6332306650163323066501 | 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)Marketed from Mar 10, 2011 |
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)
- Terbutaline Sulfate
- Generic name (nonproprietary)
- terbutaline sulfate
- Active ingredients
- Terbutaline sulfate — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076887
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1SPL ID 15846c75-dc60-4339-b97b-5c9d78d66cf1SPL set ID cec31032-f366-4524-9e01-63146e473b2bRxCUI 857635UNII 576PU70Y8EUPC 0363323665005
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
N463323066501followed by a unit qualifier and the quantityPackage 63323-0665-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Excerpt only. Read the full label for complete information.
About NDC 63323-665
- What is NDC 63323-665?
- 63323-665 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Terbutaline Sulfate.
- What is the active ingredient?
- Terbutaline sulfate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Terbutaline Sulfate?
- 16 other product NDCs are listed under this name. See all Terbutaline Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Terbutaline Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Terbutaline Sulfate | Terbutaline sulfate 1 mg/mL | Injection, SolutionSubcutaneous | Henry Schein, Inc. | 0404-9962 | 00404-9962-01 |
| Terbutaline Sulfate | Terbutaline sulfate 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-132 | 24979-0132-0124979-0132-03 |
| Terbutaline Sulfate | Terbutaline sulfate 5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-133 | 24979-0133-0124979-0133-03 |
| Terbutaline Sulfate | Terbutaline sulfate 2.5 mg/1 | TabletOral | Proficient Rx LP | 71205-938 | 71205-0938-0071205-0938-3071205-0938-55+2 more |
| Terbutaline Sulfate | Terbutaline sulfate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-939 | 71205-0939-0071205-0939-3071205-0939-55+2 more |
| Terbutaline Sulfate | Terbutaline sulfate 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-721 | 62559-0721-01 |
| Terbutaline Sulfate | Terbutaline sulfate 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-722 | 62559-0722-01 |
| Terbutaline Sulfate | Terbutaline sulfate 1 mg/mL | InjectionSubcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9375 | 00143-9375-10 |
| Terbutaline Sulfate | Terbutaline sulfate 1 mg/mL | InjectionSubcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9746 | 00143-9746-10 |
| Terbutaline Sulfate | Terbutaline sulfate 1 mg/mL | InjectionSubcutaneous | Medical Purchasing Solutions. LLC | 71872-7080 | 71872-7080-01 |
Other NDCs under ANDA 076887
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 |
|---|---|---|---|---|
| Terbutaline Sulfate | Terbutaline sulfate 1 mg/mL | Injection, SolutionSubcutaneous | Henry Schein, Inc. | 0404-9962 |