What is NDC 0115-2622?

0115-2622 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Terbutaline Sulfate NDC 0115-2622 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-2622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-2622Add 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
0115-2622-01	0011526220100115262201	100 TABLET in 1 BOTTLE (0115-2622-01)Marketed from Jun 26, 2001
0115-2622-02	0011526220200115262202	500 TABLET in 1 BOTTLE (0115-2622-02)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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075877
Marketing start: Jun 26, 2001
Listing expires: Dec 31, 2027
Identifiers: Product ID 0115-2622_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

N400115262201 followed by a unit qualifier and the quantity

Package 00115-2622-01. 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)

About NDC 0115-2622

What is NDC 0115-2622?: 0115-2622 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Terbutaline Sulfate	Terbutaline sulfate 1 mg/mL	Injection, SolutionSubcutaneous	Henry Schein, Inc.	0404-9962	00404-9962-01
Terbutaline Sulfate	Terbutaline sulfate 2.5 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	24979-132	24979-0132-0124979-0132-03
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	24979-133	24979-0133-0124979-0133-03
Terbutaline Sulfate	Terbutaline sulfate 2.5 mg/1	TabletOral	Proficient Rx LP	71205-938	71205-0938-0071205-0938-3071205-0938-55+2 more
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	Proficient Rx LP	71205-939	71205-0939-0071205-0939-3071205-0939-55+2 more
Terbutaline Sulfate	Terbutaline sulfate 2.5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-721	62559-0721-01
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-722	62559-0722-01
Terbutaline Sulfate	Terbutaline sulfate 1 mg/mL	Injection, SolutionSubcutaneous	Fresenius Kabi USA, LLC	63323-665	63323-0665-01
Terbutaline Sulfate	Terbutaline sulfate 1 mg/mL	InjectionSubcutaneous	Hikma Pharmaceuticals USA Inc.	0143-9375	00143-9375-10
Terbutaline Sulfate	Terbutaline sulfate 1 mg/mL	InjectionSubcutaneous	Hikma Pharmaceuticals USA Inc.	0143-9746	00143-9746-10

All 17 Terbutaline Sulfate NDCs

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 2.5 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-2611