Prescription drug · ANDA
Terbutaline Sulfate NDC 71205-938
Terbutaline sulfate 2.5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-938-00 | 7120509380071205093800 | 100 TABLET in 1 BOTTLE (71205-938-00)Marketed from Nov 19, 2020 | |
| 71205-938-30 | 7120509383071205093830 | 30 TABLET in 1 BOTTLE (71205-938-30)Marketed from Nov 19, 2020 | |
| 71205-938-55 | 7120509385571205093855 | 500 TABLET in 1 BOTTLE (71205-938-55)Marketed from Nov 19, 2020 | |
| 71205-938-60 | 7120509386071205093860 | 60 TABLET in 1 BOTTLE (71205-938-60)Marketed from Nov 19, 2020 | |
| 71205-938-90 | 7120509389071205093890 | 90 TABLET in 1 BOTTLE (71205-938-90)Marketed from Nov 19, 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)
- Terbutaline Sulfate
- Generic name (nonproprietary)
- terbutaline sulfate
- Active ingredients
- Terbutaline sulfate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211832
- Marketing start
- Listing expires
- Identifiers
- Product ID 71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905SPL ID 9f8ee6b8-61e1-478a-90de-57358fdb5905SPL set ID 0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7RxCUI 857677, 857683UNII 576PU70Y8EUPC 0371205939304, 0371205938307
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471205093800followed by a unit qualifier and the quantityPackage 71205-0938-00. 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 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 71205-938
- What is NDC 71205-938?
- 71205-938 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 2.5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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 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 211832
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 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-132 |
| Terbutaline Sulfate | Terbutaline sulfate 5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-133 |
| Terbutaline Sulfate | Terbutaline sulfate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-939 |