NDC 72205-200-11 - 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
- 72205-200
- Requested NDC
- 72205-200-11
- Package NDCs from labels
- 72205-200-30, 72205-200-90, 72205-200-11, 72205-200-06
- Manufacturer
- Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc.
- Effective date
- 2024-08-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Roflumilast | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 2024-08-27 | Human Prescription Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72205-200-06 | Roflumilast | 10 in 1 CARTON | TABLET | 10 | 3 | |
| 72205-200-11 | Roflumilast | 10 in 1 BLISTER PACK | TABLET | 10 | 3 | |
| 72205-200-30 | Roflumilast | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 72205-200-90 | Roflumilast | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72205-200-30 | EA - Each | 72205-200 | 015f9d85-d981-4de7-a9b5-16f96ad84dee | 1 | 2022-11-07 |
| 72205-200-90 | EA - Each | 72205-200 | d0e8287a-ca75-4fd4-a5e6-f29ea6bb6343 | 1 | 2022-11-07 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | f9e0b4a9-a227-4947-b00c-41fb18d16589 | 2026-09-02 | Warnings, Adverse reactions | 0P6C6ZOP5U |
| ROFLUMILAST | ROFLUMILAST | Amici Pharma Inc. | cb3781ff-5350-4f9a-b247-0b04eb0f2b92 | 2026-09-01 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | 6OZP39ZG8H |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | 6OZP39ZG8H |
| ZORYVE | ROFLUMILAST | Arcutis Biotherapeutics, Inc. | ec1bb0d1-f38a-4080-831a-68791d1d1fdb | 2026-07-20 | Adverse reactions | 0P6C6ZOP5U |
| Roflumilast | ROFLUMILAST | Jubilant Cadista Pharmaceuticals Inc. | aaa81c1b-f63d-4e61-8bfa-9d42d92043c7 | 2026-07-14 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| roflumilast | ROFLUMILAST | AvKARE | 55009549-3f0c-1f58-e063-6294a90a6c03 | 2026-06-24 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| Rohto Cool Relief | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 | 2026-06-19 | Warnings | 6OZP39ZG8H |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | O8232NY3SJ |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | O8232NY3SJ |
| Refresh Optive Mega-3 PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | 326cb5d6-c784-404f-9a13-6d69262dda6e | 2026-03-01 | Warnings | 6OZP39ZG8H |
| Lotrimin Daily Sweat and Odor Control | TOPICAL STARCH | Bayer HealthCare LLC. | 9ec5c80d-b550-496f-e053-2a95a90a5489 | 2026-01-16 | Warnings | O8232NY3SJ |
| Medicated Cornstarch Baby Powder | ACTIVE CORN STARCH | Davion, Inc. | e39032d1-c8cd-4a41-af10-126970b8ad38 | 2025-12-29 | Warnings | O8232NY3SJ |
| Roflumilast | ROFLUMILAST | Major Pharmaceuticals | ca22f3e0-6f33-4f1c-97e5-0c962891067a | 2025-12-10 | Warnings, Adverse reactions | ANDA208256 1091839 0P6C6ZOP5U |
| Roflumilast | ROFLUMILAST | MAJOR PHARMACEUTICALS | c51b80f3-a591-4db9-81b4-b91603e35d7c | 2025-12-04 | Warnings, Adverse reactions | ANDA208256 2001319 1091839 0P6C6ZOP5U |
| ROFLUMILAST | ROFLUMILAST | Micro Labs Limited | dc2a689f-cfa4-4863-9623-a9813dcf86a9 | 2025-07-24 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| ROFLUMILAST | ROFLUMILAST | Aurobindo Pharma Limited | 7cb11d48-6bb9-437b-bc7f-382050a2d3e6 | 2025-05-27 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| Roflumilast | ROFLUMILAST | Golden State Medical Supply, Inc. | 30dd6eae-6435-cae1-e063-6294a90a003b | 2025-03-21 | Warnings, Adverse reactions | 1091839 0P6C6ZOP5U |
| Roflumilast | ROFLUMILAST | Ascend Laboratories, LLC | 93d72a99-64dc-4fde-a5b8-78331fa60787 | 2025-03-13 | Warnings, Adverse reactions | 2001319 1091839 0P6C6ZOP5U |
| Roflumilast | ROFLUMILAST | American Health Packaging | 913f1b95-9c46-40d5-a6e9-cff2e5e07eaa | 2024-11-21 | Warnings, Adverse reactions | 1091839 0P6C6ZOP5U |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.