What is NDC 0093-4061?

0093-4061 is the product NDC for Formoterol fumarate, Formoterol fumarate 20 ug/2mL solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Formoterol fumarate?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Formoterol fumarate NDC 0093-4061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-4061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-4061Add 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
0093-4061-06	0009340610600093406106	60 POUCH in 1 CARTON (0093-4061-06) / 1 VIAL in 1 POUCH / 2 mL in 1 VIALMarketed from Jun 22, 2021
0093-4061-30	0009340613000093406130	30 POUCH in 1 CARTON (0093-4061-30) / 1 VIAL in 1 POUCH (0093-4061-19) / 2 mL in 1 VIALMarketed from Jun 22, 2021

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): Formoterol fumarate
Generic name (nonproprietary): formoterol fumarate
Active ingredients: Formoterol fumarate — 20 ug/2mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091141
Marketing start: Jun 22, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8SPL ID 0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8SPL set ID 419bc85d-8e24-478b-921e-babfb73e79f3RxCUI 1246319UNII W34SHF8J2K
Pharmacologic class: beta2-Adrenergic Agonist

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.

NDC on a medical claim

N400093406106 followed by a unit qualifier and the quantity

Package 00093-4061-06. 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 Oct 31, 2020.

Indications (excerpt from the label)

Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Formoterol fumarate inhalation solution is not indicated to treat asthma. ( 1.2 ) 1.1 Maintenance Treatment of COPD Formoterol fumarate inhalation solution is indicated for the long-t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-4061

What is NDC 0093-4061?: 0093-4061 is the product NDC for Formoterol fumarate, Formoterol fumarate 20 ug/2mL solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Formoterol fumarate.
What is the active ingredient?: Formoterol fumarate.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Formoterol fumarate?: 11 other product NDCs are listed under this name. See all Formoterol fumarate 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 Formoterol fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Formoterol fumarateformoterol fumarate dihydrate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Devatis, Inc.	73043-051	73043-0051-9373043-0051-96
Formoterol Fumarate	Formoterol fumarate .02 mg/2mL	SolutionRespiratory (Inhalation)	Ingenus Pharmaceuticals, LLC	50742-394	50742-0394-3050742-0394-60
Formoterol Fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Dr. Reddy's Laboratories Inc.	43598-778	43598-0778-3043598-0778-60
Formoterol fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Micro Labs Limited	42571-463	42571-0463-6242571-0463-73
Formoterol fumarateformoterol fumarate dihydrate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-620	72603-0620-3072603-0620-60
Formoterol fumarateformoterol fumarate dihydrate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Lifestar Pharma LLC	70756-608	70756-0608-6070756-0608-70
formoterol fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Lupin Pharmaceuticals, Inc.	70748-261	70748-0261-3070748-0261-60
Formoterol Fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Alembic Pharmaceuticals Inc.	62332-655	62332-0655-3062332-0655-60
Formoterol Fumarateformoterol fumarate dihydrate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-1631	00378-1631-9100378-1631-93
Formoterol fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Bryant Ranch Prepack	63629-8813	63629-8813-01

All 12 Formoterol fumarate NDCs

Other NDCs under ANDA 091141

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

FDA NDC Directory listings under ANDA 091141
Product	Strength	Form · route	Labeler	Product NDC
Formoterol fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Bryant Ranch Prepack	63629-8813
Formoterol fumarate	Formoterol fumarate 20 ug/2mL	SolutionRespiratory (Inhalation)	Bryant Ranch Prepack	63629-8814