NDC codes

FDA NDC Directory
Product NDC (as listed)62559-722Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0722Add 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
62559-722-016255907220162559072201100 TABLET in 1 BOTTLE (62559-722-01)Marketed from Oct 16, 2018

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 017849
Marketing start
Listing expires
Identifiers
Product ID 62559-722_ee722f8c-05d6-43bc-825d-9496579032c4SPL ID ee722f8c-05d6-43bc-825d-9496579032c4SPL set ID d810a15b-3e10-4f6c-a36e-8ddecbaba9c3RxCUI 857677, 857683UNII 576PU70Y8EUPC 0362559721011, 0362559722018

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

N462559072201 followed by a unit qualifier and the quantity

Package 62559-0722-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Terbutaline Sulfate Tablets USP 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)

About NDC 62559-722

What is NDC 62559-722?
62559-722 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 5 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, 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?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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 1 mg/mLInjection, SolutionSubcutaneousHenry Schein, Inc.0404-996200404-9962-01
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 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 NDA 017849

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

FDA NDC Directory listings under NDA 017849
ProductStrengthForm · routeLabelerProduct NDC
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralANI Pharmaceuticals, Inc.62559-721

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