Prescription drug · ANDA
Terbutaline Sulfate NDC 0404-9962
Terbutaline sulfate 1 mg/mL · Injection, Solution · Subcutaneous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9962-01 | 0040499620100404996201 | 1 VIAL in 1 BAG (0404-9962-01) / 1 mL in 1 VIALMarketed from Jan 12, 2022 |
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)
- Terbutaline Sulfate
- Generic name (nonproprietary)
- terbutaline sulfate
- Active ingredients
- Terbutaline sulfate — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076887
- Marketing start
- Marketing end
- Identifiers
- Product ID 0404-9962_71e41b5f-46c2-4c2d-8f63-e164903d16f6SPL ID 71e41b5f-46c2-4c2d-8f63-e164903d16f6SPL set ID 9f4b177e-4d7d-4255-afeb-522c7d4594c6RxCUI 857635UNII 576PU70Y8E
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
N400404996201followed by a unit qualifier and the quantityPackage 00404-9962-01. 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 .
Indications (excerpt from the label)
INDICATIONS & 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 0404-9962
- What is NDC 0404-9962?
- 0404-9962 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 1 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. 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?
- Henry Schein, Inc., NDC labeler code 0404. 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 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 | Injection, SolutionSubcutaneous | Fresenius Kabi USA, LLC | 63323-665 | 63323-0665-01 |
| 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 | Fresenius Kabi USA, LLC | 63323-665 |