NDC 42571-369-32 - ROFLUMILAST

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 42571-369
Requested NDC: 42571-369-32
Package NDCs from labels: 42571-369-83, 42571-369-30, 42571-369-90, 42571-369-05, 42571-369-32, 42571-369-11
Manufacturer: Micro Labs Limited
Effective date: 2025-07-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ROFLUMILAST - Micro Labs Limited	Micro Labs Limited	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-369-05	ROFLUMILAST	500 in 1 BOTTLE	TABLET	500	6
42571-369-11	ROFLUMILAST	10 in 1 CARTON	TABLET	10	6
42571-369-30	ROFLUMILAST	30 in 1 BOTTLE	TABLET	30	6
42571-369-32	ROFLUMILAST	10 in 1 BLISTER PACK	TABLET	10	6
42571-369-83	ROFLUMILAST	28 in 1 BOTTLE	TABLET	28	6
42571-369-90	ROFLUMILAST	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-369	ROFLUMILAST TABLET ROFLUMILAST TABLET [MICRO LABS LIMITED]	5	Current NDC, 6 package rows	20230502_dc2a689f-cfa4-4863-9623-a9813dcf86a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-369-83	EA - Each	42571-369	fbee6b5d-92a1-4be4-9007-aba0444c7ee7	1	2023-07-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Roflumilast	ROFLUMILAST	Jubilant Cadista Pharmaceuticals Inc.	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	2026-07-14	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	2026-07-02	Adverse reactions	Exact identifier unii: 0P6C6ZOP5U
roflumilast	ROFLUMILAST	AvKARE	55009549-3f0c-1f58-e063-6294a90a6c03	2026-06-24	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	f9e0b4a9-a227-4947-b00c-41fb18d16589	2026-06-22	Warnings, Adverse reactions	Exact identifier unii: 0P6C6ZOP5U
ROFLUMILAST	ROFLUMILAST	Amici Pharma Inc.	cb3781ff-5350-4f9a-b247-0b04eb0f2b92	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor Control	TOPICAL STARCH	Bayer HealthCare LLC.	9ec5c80d-b550-496f-e053-2a95a90a5489	2026-01-16	Warnings	Exact identifier unii: O8232NY3SJ
Medicated Cornstarch Baby Powder	ACTIVE CORN STARCH	Davion, Inc.	e39032d1-c8cd-4a41-af10-126970b8ad38	2025-12-29	Warnings	Exact identifier unii: O8232NY3SJ
Roflumilast	ROFLUMILAST	Major Pharmaceuticals	ca22f3e0-6f33-4f1c-97e5-0c962891067a	2025-12-10	Warnings, Adverse reactions	Exact identifier rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	MAJOR PHARMACEUTICALS	c51b80f3-a591-4db9-81b4-b91603e35d7c	2025-12-04	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
ROFLUMILAST	ROFLUMILAST	Micro Labs Limited	dc2a689f-cfa4-4863-9623-a9813dcf86a9	2025-07-24	Warnings, Adverse reactions	Exact identifier application number: ANDA208180 ndc (package): 42571-369-32 ndc (package): 42571-259-90 ndc (package): 42571-369-05 ndc (package): 42571-369-11 ndc (package): 42571-259-17 ndc (package): 42571-369-30 ndc (package): 42571-259-05 ndc (package): 42571-259-30 ndc (package): 42571-369-90 ndc (package): 42571-259-32 ndc (package): 42571-369-83 ndc (product): 42571-369 ndc (product): 42571-259 ndc11 (package): 42571036932 rxcui: 2001319 rxcui: 1091839 spl id: 3aacb2a6-70a4-650d-e063-6394a90af9fc spl set id: dc2a689f-cfa4-4863-9623-a9813dcf86a9 unii: 0P6C6ZOP5U
ROFLUMILAST	ROFLUMILAST	Aurobindo Pharma Limited	7cb11d48-6bb9-437b-bc7f-382050a2d3e6	2025-05-27	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	Golden State Medical Supply, Inc.	30dd6eae-6435-cae1-e063-6294a90a003b	2025-03-21	Warnings, Adverse reactions	Exact identifier rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	Ascend Laboratories, LLC	93d72a99-64dc-4fde-a5b8-78331fa60787	2025-03-13	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	American Health Packaging	913f1b95-9c46-40d5-a6e9-cff2e5e07eaa	2024-11-21	Warnings, Adverse reactions	Exact identifier rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	Novadoz Pharmaceuticals LLC	4d25f69c-58b7-4e2a-b835-4d0c76a83c7c	2024-08-27	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	Zydus Pharmaceuticals USA Inc.	84145572-f320-4c3f-ab29-bd9f6c18746c	2024-08-16	Warnings, Adverse reactions	Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U
ROFLUMILAST	ROFLUMILAST	Bryant Ranch Prepack	fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72	2024-08-15	Warnings, Adverse reactions	Exact identifier application number: ANDA208180 rxcui: 1091839 unii: 0P6C6ZOP5U
Roflumilast	ROFLUMILAST	Zydus Lifesciences Limited	e87287bd-eae3-46c3-9072-04800aeabf40	2024-08-12		Exact identifier rxcui: 2001319 rxcui: 1091839 unii: 0P6C6ZOP5U