What is NDC 0527-1318?

0527-1318 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 2.5 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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 0527-1318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1318Add 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
0527-1318-01	0052713180100527131801	100 TABLET in 1 BOTTLE (0527-1318-01)Marketed from Mar 25, 2005
0527-1318-10	0052713181000527131810	1000 TABLET in 1 BOTTLE (0527-1318-10)Marketed from Mar 25, 2005

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077152
Marketing start: Mar 25, 2005
Listing expires: Dec 31, 2027
Identifiers: Product ID 0527-1318_75d6b891-2c50-4748-829a-3567ee966978SPL ID 75d6b891-2c50-4748-829a-3567ee966978SPL set ID fbf54709-5857-4dbc-9233-ebd7abff88c8RxCUI 857677, 857683UNII 576PU70Y8EUPC 0305271318015

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

N400527131801 followed by a unit qualifier and the quantity

Package 00527-1318-01. 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 Nov 12, 2020. 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 0527-1318

What is NDC 0527-1318?: 0527-1318 is the product NDC for Terbutaline Sulfate, Terbutaline sulfate 2.5 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. 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?: Lannett Company, Inc., NDC labeler code 0527. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	Lannett Company, Inc.	0527-1311
Terbutaline Sulfate	Terbutaline sulfate 2.5 mg/1	TabletOral	Chartwell RX, LLC.	62135-524
Terbutaline Sulfate	Terbutaline sulfate 5 mg/1	TabletOral	Chartwell RX, LLC.	62135-525