ROFLUMILAST

Product NDC
59651-275
11-digit product format
596510275
Labeler code
59651
Product ID
59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROFLUMILAST
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213298
Marketing category
ANDA
Marketing start
2023-04-17
Substance
ROFLUMILAST
Active strength
500 ug/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213298-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2023-04-17
A213298-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2025-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213298-001AB
A213298-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-178072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-173f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213298-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213298-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213298-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213298-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213298-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213298-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213298-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213298-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213298-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213298-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213298-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213298-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213298-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213298-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213298-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213298-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213298-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213298-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213298-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213298-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213298-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213298-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213298-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213298-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213298-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213298-001AB13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213298-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213298-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROFLUMILASTROFLUMILASTAurobindo Pharma Limited7cb11d48-6bb9-437b-bc7f-382050a2d3e62025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213298
application number: ANDA213298
ndc (product): 59651-275

Additional Listing Data#

Finished product
Yes
Brand name base
ROFLUMILAST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST500 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0P6C6ZOP5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091839Internal RxNorm lookup
2001319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7cb11d48-6bb9-437b-bc7f-382050a2d3e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcb8b904-8d4f-458b-b954-4eae028a2651Product name220250305
a1a743b6-f2e2-4044-a176-5c60c71ece24Product name120250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7Product name920240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-275-30ROFLUMILAST30 in 1 BOTTLETABLET306
59651-275-90ROFLUMILAST90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-275-30EA - Each59651-275b56bddb7-e1d9-4d47-87d4-41201e8b8e3912023-05-05
59651-275-90EA - Each59651-275318d2c65-de8d-460b-ba82-9a6f2925c27d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-275ROFLUMILAST TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, 2 package rows20250529_7cb11d48-6bb9-437b-bc7f-382050a2d3e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSN7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 500 MCG Oral TabletPSN7cb11d48-6bb9-437b-bc7f-382050a2d3e66
2001319roflumilast 0.25 MG Oral TabletSCD7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 0.5 MG Oral TabletSCD7cb11d48-6bb9-437b-bc7f-382050a2d3e66
2001319roflumilast 250 MCG Oral TabletSY7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 500 MCG Oral TabletSY7cb11d48-6bb9-437b-bc7f-382050a2d3e66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-275-305965102753030 TABLET in 1 BOTTLE (59651-275-30) 30 tablet2023-04-17NoNoCurrent
59651-275-905965102759090 TABLET in 1 BOTTLE (59651-275-90) 90 tablet2023-04-17NoNoCurrent