NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9962Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9962Add 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 NDC11-digit (billing)PackageCopy
0404-9962-0100404996201004049962011 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.

How CPT relates to drug billing

NDC on a medical claim

N400404996201 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Terbutaline Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralUpsher-Smith Laboratories, LLC24979-13224979-0132-0124979-0132-03
Terbutaline SulfateTerbutaline sulfate 5 mg/1TabletOralUpsher-Smith Laboratories, LLC24979-13324979-0133-0124979-0133-03
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralProficient Rx LP71205-93871205-0938-0071205-0938-3071205-0938-55+2 more
Terbutaline SulfateTerbutaline sulfate 5 mg/1TabletOralProficient Rx LP71205-93971205-0939-0071205-0939-3071205-0939-55+2 more
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralANI Pharmaceuticals, Inc.62559-72162559-0721-01
Terbutaline SulfateTerbutaline sulfate 5 mg/1TabletOralANI Pharmaceuticals, Inc.62559-72262559-0722-01
Terbutaline SulfateTerbutaline sulfate 1 mg/mLInjection, SolutionSubcutaneousFresenius Kabi USA, LLC63323-66563323-0665-01
Terbutaline SulfateTerbutaline sulfate 1 mg/mLInjectionSubcutaneousHikma Pharmaceuticals USA Inc.0143-937500143-9375-10
Terbutaline SulfateTerbutaline sulfate 1 mg/mLInjectionSubcutaneousHikma Pharmaceuticals USA Inc.0143-974600143-9746-10
Terbutaline SulfateTerbutaline sulfate 1 mg/mLInjectionSubcutaneousMedical Purchasing Solutions. LLC71872-708071872-7080-01

All 17 Terbutaline Sulfate NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Terbutaline SulfateTerbutaline sulfate 1 mg/mLInjection, SolutionSubcutaneousFresenius Kabi USA, LLC63323-665

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