What is NDC 70771-1673?

70771-1673 is the product NDC for Roflumilast, Roflumilast 250 ug/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1673 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1673Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1673Add 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
70771-1673-3	70771167303	2 BLISTER PACK in 1 CARTON (70771-1673-3) / 10 TABLET in 1 BLISTER PACK (70771-1673-2)Marketed from May 18, 2023
70771-1673-8	70771167308	1 BLISTER PACK in 1 CARTON (70771-1673-8) / 28 TABLET in 1 BLISTER PACKMarketed from May 18, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 250 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208303
Marketing start: May 18, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 70771-1673_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6SPL ID eb40db9e-ddc1-4041-aac5-ff0f2c478fc6SPL set ID e87287bd-eae3-46c3-9072-04800aeabf40RxCUI 1091839, 2001319UNII 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

N470771167303 followed by a unit qualifier and the quantity

Package 70771-1673-03. 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 Aug 12, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1673

What is NDC 70771-1673?: 70771-1673 is the product NDC for Roflumilast, Roflumilast 250 ug/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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?: Zydus Lifesciences Limited, NDC labeler code 70771. 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 250 ug/1	TabletOral	AvKARE	73190-086	73190-0086-28
roflumilast	Roflumilast 500 ug/1	TabletOral	AvKARE	73190-087	73190-0087-3073190-0087-90
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 500 ug/1	TabletOral	Ascend Laboratories, LLC	67877-480	67877-0480-0567877-0480-3067877-0480-33+1 more
Roflumilast	Roflumilast 250 ug/1	TabletOral	Ascend Laboratories, LLC	67877-730	67877-0730-0567877-0730-3067877-0730-87+2 more
Roflumilast	Roflumilast 250 ug/1	TabletOral	Aurobindo Pharma Limited	59651-801	59651-0801-2059651-0801-28

All 27 Roflumilast NDCs

Other NDCs under ANDA 208303

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

FDA NDC Directory listings under ANDA 208303
Product	Strength	Form · route	Labeler	Product NDC
Roflumilast	Roflumilast 250 ug/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-624
Roflumilast	Roflumilast 500 ug/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-969
Roflumilast	Roflumilast 500 ug/1	TabletOral	Zydus Lifesciences Limited	70771-1674