NDC codes

FDA NDC Directory
Product NDC (as listed)70756-608Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0608Add 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
70756-608-607075606086060 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIALMarketed from Mar 22, 2023
70756-608-707075606087030 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIALMarketed from Mar 22, 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)
Formoterol fumarate
Generic name (nonproprietary)
formoterol fumarate dihydrate
Active ingredients
Formoterol fumarate — 20 ug/2mL
Dosage form
Solution
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215883
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)
Identifiers
Product ID 70756-608_7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2aSPL ID 7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2aSPL set ID 35538d89-a984-4335-acdf-85a893f51eeeRxCUI 1246319UNII W34SHF8J2KUPC 0370756608127
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

N470756060860 followed by a unit qualifier and the quantity

Package 70756-0608-60. 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 .

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)

Other NDCs under ANDA 215883

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

FDA NDC Directory listings under ANDA 215883
ProductStrengthForm · routeLabelerProduct NDC
Formoterol fumarateformoterol fumarate dihydrateFormoterol fumarate 20 ug/2mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-620

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