Terbutaline Sulfate NDC 0115-2611

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-2611Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-2611Add 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 NDC	11-digit (billing)	Package	Copy
0115-2611-01	00115261101	100 TABLET in 1 BOTTLE (0115-2611-01)Marketed from Jun 26, 2001
0115-2611-02	00115261102	500 TABLET in 1 BOTTLE (0115-2611-02)Marketed from Jun 26, 2001

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075877
Marketing start: Jun 26, 2001
Listing expires: Dec 31, 2026
Identifiers: Product ID 0115-2611_63142944-3083-4d47-908f-2984144b6c5dSPL ID 63142944-3083-4d47-908f-2984144b6c5dSPL set ID 382dcebb-6e41-4335-818d-b5822e3fb884RxCUI 857677, 857683UNII 576PU70Y8EUPC 0301152622011, 0301152611015

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

N400115261101 followed by a unit qualifier and the quantity

Package 00115-2611-01. 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 Jul 29, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Terbutaline sulfate tablets are 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075877

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

FDA NDC Directory listings under ANDA 075877
Product	Strength	Form · route	Labeler	Product NDC
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-2622