What is NDC 43547-005?

43547-005 is the product NDC for Roflumilast, Roflumilast 500 ug/1 tablet, listed with the FDA by Solco Healthcare US, LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Solco Healthcare US, LLC., NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Roflumilast?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Roflumilast NDC 43547-005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0005Add 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
43547-005-03	43547000503	30 TABLET in 1 BOTTLE (43547-005-03)Marketed from May 10, 2022
43547-005-09	43547000509	90 TABLET in 1 BOTTLE (43547-005-09)Marketed from May 10, 2022

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): Roflumilast
Generic name (nonproprietary): roflumilast
Active ingredients: Roflumilast — 500 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare US, LLC.NDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208299
Marketing start: May 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cdSPL ID 4251c764-7224-4f94-9de7-b6c76cb1f5cdSPL set ID 4251c764-7224-4f94-9de7-b6c76cb1f5cdRxCUI 1091839UNII 0P6C6ZOP5U
Pharmacologic class: Phosphodiesterase 4 Inhibitor

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

N443547000503 followed by a unit qualifier and the quantity

Package 43547-0005-03. 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 May 10, 2022.

Indications (excerpt from the label)

Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. ( 1 , 14 ) Limitations of Use: • Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1 , 14 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-005

What is NDC 43547-005?: 43547-005 is the product NDC for Roflumilast, Roflumilast 500 ug/1 tablet, listed with the FDA by Solco Healthcare US, LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Roflumilast.
What is the active ingredient?: Roflumilast.
Who is the labeler?: Solco Healthcare US, LLC., NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Roflumilast?: 26 other product NDCs are listed under this name. See all Roflumilast 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 Roflumilast NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
roflumilast	Roflumilast 500 ug/1	TabletOral	AvKARE	73190-087	73190-0087-3073190-0087-90
roflumilast	Roflumilast 250 ug/1	TabletOral	AvKARE	73190-086	73190-0086-28
Roflumilast	Roflumilast 250 ug/1	TabletOral	Amici Pharma Inc.	69292-630	69292-0630-1069292-0630-1469292-0630-20+1 more
Roflumilast	Roflumilast 500 ug/1	TabletOral	Amici Pharma Inc.	69292-631	69292-0631-3069292-0631-90
Roflumilast	Roflumilast 250 ug/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-801	59746-0801-70
Roflumilast	Roflumilast 500 ug/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-802	59746-0802-0559746-0802-3059746-0802-90
Roflumilast	Roflumilast 250 ug/1	TabletOral	MAJOR PHARMACEUTICALS	0904-7493	00904-7493-71
Roflumilast	Roflumilast 250 ug/1	TabletOral	Ascend Laboratories, LLC	67877-730	67877-0730-0567877-0730-3067877-0730-87+2 more
Roflumilast	Roflumilast 500 ug/1	TabletOral	Ascend Laboratories, LLC	67877-480	67877-0480-0567877-0480-3067877-0480-33+1 more
Roflumilast	Roflumilast 250 ug/1	TabletOral	Aurobindo Pharma Limited	59651-801	59651-0801-2059651-0801-28

All 27 Roflumilast NDCs