NDC codes

FDA NDC Directory
Product NDC (as listed)62135-525Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0525Add 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
62135-525-90621350525906213505259090 TABLET in 1 BOTTLE (62135-525-90)Marketed from Feb 28, 2023

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
Chartwell RX, LLC.NDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077152
Marketing start
Listing expires
Identifiers
Product ID 62135-525_459ef32e-2348-14bd-e063-6394a90a6a90SPL ID 459ef32e-2348-14bd-e063-6394a90a6a90SPL set ID 859267c6-3d14-4123-9b9d-4fc248f09726RxCUI 857677, 857683UNII 576PU70Y8EUPC 0362135524906, 0362135525903

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

N462135052590 followed by a unit qualifier and the quantity

Package 62135-0525-90. 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.

Full label on DailyMed (opens in a new tab)

About NDC 62135-525

What is NDC 62135-525?
62135-525 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 5 mg/1 tablet, listed with the FDA by Chartwell RX, LLC.. 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?
Chartwell RX, LLC., NDC labeler code 62135. 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 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

All 17 Terbutaline Sulfate NDCs

Other NDCs under ANDA 077152

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

FDA NDC Directory listings under ANDA 077152
ProductStrengthForm · routeLabelerProduct NDC
Terbutaline SulfateTerbutaline sulfate 5 mg/1TabletOralLannett Company, Inc.0527-1311
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralLannett Company, Inc.0527-1318
Terbutaline SulfateTerbutaline sulfate 2.5 mg/1TabletOralChartwell RX, LLC.62135-524

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