Terbutaline Sulfate NDC 63323-665

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-665Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0665Add 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
63323-665-01	63323066501	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, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076887
Marketing start: Mar 10, 2011
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N463323066501 followed by a unit qualifier and the quantity

Package 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 Jul 12, 2022. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076887

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

FDA NDC Directory listings under ANDA 076887
Product	Strength	Form · route	Labeler	Product NDC
Terbutaline Sulfate	Terbutaline sulfate 1 mg/mL	Injection, SolutionSubcutaneous	Henry Schein, Inc.	0404-9962