Roflumilast

Product NDC
51407-975
11-digit product format
514070975
Labeler code
51407
Product ID
51407-975_30dd6be3-6f60-c6a9-e063-6294a90afaa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA212490
Marketing category
ANDA
Marketing start
2023-04-18
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
A212490-001ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2023-04-18
A212490-002ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212490-001AB
A212490-002AB

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-186a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-181c564ffb4f44…
2024-02-18 07:12 UTC2024-02A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-189b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212490-001ROFLUMILAST250MCGTABLET / ORALAB2023-04-18a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212490-002ROFLUMILAST500MCGTABLET / ORALAB2023-04-18a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212490-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212490-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212490-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212490-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212490-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212490-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212490-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212490-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212490-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212490-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212490-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212490-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212490-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212490-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212490-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212490-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212490-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212490-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212490-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212490-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212490-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212490-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212490-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212490-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212490-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212490-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212490-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212490-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212490-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212490-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212490-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A212490-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212490-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A212490-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212490-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212490-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212490-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212490-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212490-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212490-002AB1a67488948f0b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoflumilastROFLUMILASTGolden State Medical Supply, Inc.30dd6eae-6435-cae1-e063-6294a90a003b2025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212490
application number: ANDA212490
ndc (product): 51407-975
RoflumilastROFLUMILASTAscend Laboratories, LLC93d72a99-64dc-4fde-a5b8-78331fa607872025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212490
application number: ANDA212490

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30dd6eae-6435-cae1-e063-6294a90a003bAvailable 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
51407-975-90Roflumilast90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-975-90EA - Each51407-9756a19ef38-dd14-4583-ad5f-dd09edc9fb8812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-975ROFLUMILAST TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20250326_30dd6eae-6435-cae1-e063-6294a90a003b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091839roflumilast 500 MCG Oral TabletPSN30dd6eae-6435-cae1-e063-6294a90a003b1
1091839roflumilast 0.5 MG Oral TabletSCD30dd6eae-6435-cae1-e063-6294a90a003b1
1091839roflumilast 500 MCG Oral TabletSY30dd6eae-6435-cae1-e063-6294a90a003b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-975-905140709759090 TABLET in 1 BOTTLE (51407-975-90) 90 tablet2025-02-13NoNoCurrent