Mavenclad

Product NDC
44087-4000
11-digit product format
440874000
Labeler code
44087
Product ID
44087-4000_4f6e2bce-df90-4b30-a969-59810b302b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cladribine
Dosage form
TABLET
Route
ORAL
Labeler
EMD Serono, Inc.
Application
NDA022561
Marketing category
NDA
Marketing start
2019-04-01
Substance
CLADRIBINE
Active strength
10 mg/1
Pharmacologic classes
Purine Antimetabolite [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022561-001MAVENCLADCLADRIBINE10MGTABLET / ORALABRLD, RS2019-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022561-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022561-001108499192038-11-23U-34112022-09-09
N022561-001125334082041-09-10U-43952026-01-27
N022561-001125393292041-09-10U-43992026-02-03

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022561-001MAVENCLAD10MGTABLET / ORALABRLD, RS2019-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022561-001MAVENCLAD10MGTABLET / ORALABRLD, RS2019-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022561-001MAVENCLAD10MGTABLET / ORALRLD, RS2019-03-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022561-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022561-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022561-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022561-00183779032026-05-31U-25222019-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022561-00177139472026-10-16U-25202019-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022561-001108499192038-11-23U-34112022-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022561-001125334082041-09-10U-43952026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022561-001125393292041-09-10U-43992026-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022561-00183779032026-05-31U-25222019-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022561-00177139472026-10-16U-25202019-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022561-001108499192038-11-23U-34112022-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022561-00183779032026-05-31U-25222019-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022561-00177139472026-10-16U-25202019-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022561-001108499192038-11-23U-34112022-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022561-00183779032026-05-31U-25222019-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022561-00177139472026-10-16U-25202019-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022561-001108499192038-11-23U-34112022-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022561-00183779032026-05-31U-25222019-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022561-00177139472026-10-16U-25202019-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022561-001108499192038-11-23U-34112022-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-00178883282024-04-11U-2521Drug product2019-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-00187854152024-04-11U-2523Drug product2019-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-00183779032026-05-31U-25222019-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-00177139472026-10-16U-25202019-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022561-001108499192038-11-23U-34112022-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-00178883282024-04-11U-2521Drug product2019-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-00187854152024-04-11U-2523Drug product2019-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-00183779032026-05-31U-25222019-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-00177139472026-10-16U-25202019-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022561-001108499192038-11-23U-34112022-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-00178883282024-04-11U-2521Drug product2019-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-00187854152024-04-11U-2523Drug product2019-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-00183779032026-05-31U-25222019-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-00177139472026-10-16U-25202019-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022561-001108499192038-11-23U-34112022-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-00178883282024-04-11U-2521Drug product2019-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-00187854152024-04-11U-2523Drug product2019-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-00183779032026-05-31U-25222019-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-00177139472026-10-16U-25202019-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022561-001108499192038-11-23U-34112022-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022561-00178883282024-04-11U-2521Drug product2019-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N022561-00187854152024-04-11U-2523Drug product2019-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N022561-00183779032026-05-31U-25222019-05-28d06236e962d9…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022561-001NP2022-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022561-001NP2022-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022561-001NP2022-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022561-001NP2022-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022561-001NP2022-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022561-001NP2022-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022561-001NP2022-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N022561-001NP2022-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022561-001NP2022-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022561-001NP2022-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022561-001NP2022-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09N022561-001NP2022-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N022561-001NP2022-03-29ea99ee380514…
2023-01-26 05:58 UTC2023-01N022561-001NP2022-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022561-001NP2022-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022561-001NP2022-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022561-001NP2022-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022561-001NP2022-03-29cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Mavenclad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLADRIBINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47M74X9YT5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2122634Internal RxNorm lookup
2122635Internal RxNorm lookup
2122641Internal RxNorm lookup
2122642Internal RxNorm lookup
2122647Internal RxNorm lookup
2122648Internal RxNorm lookup
2122649Internal RxNorm lookup
2122650Internal RxNorm lookup
2122654Internal RxNorm lookup
2122655Internal RxNorm lookup
2122656Internal RxNorm lookup
2122657Internal RxNorm lookup
2122658Internal RxNorm lookup
2122659Internal RxNorm lookup
2122660Internal RxNorm lookup
2122661Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c75e30a-a410-40f1-b653-04d532bd9144Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e6341a9e-3b90-6d63-7529-e3c0b6be164aProduct name220200511
21075a88-376d-46da-a075-a9797650ce34Product name120190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
44087-4000-02024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92024-01-30These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-02022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92022-02-02These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-02022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-42022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-52022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-62022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-72022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-82022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993
44087-4000-92022-01-28These highlights do not include all the information needed to use MAVENCLAD safely and effectively. See full prescribing information for MAVENCLAD. MAVENCLAD ® (cladribine) tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-4000-0Mavenclad2 in 1 BLISTER PACKTABLET210
44087-4000-0Mavenclad5 in 1 CARTONTABLET510
44087-4000-4Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-4Mavenclad4 in 1 CARTONTABLET410
44087-4000-5Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-5Mavenclad5 in 1 CARTONTABLET510
44087-4000-6Mavenclad6 in 1 CARTONTABLET610
44087-4000-6Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-7Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-7Mavenclad7 in 1 CARTONTABLET710
44087-4000-8Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-8Mavenclad8 in 1 CARTONTABLET810
44087-4000-9Mavenclad1 in 1 BLISTER PACKTABLET110
44087-4000-9Mavenclad9 in 1 CARTONTABLET910

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-4000-0EA - Each44087-400072629d0a-cb99-46d3-a443-715cd568936812019-06-19
44087-4000-4EA - Each44087-4000cfa9f57c-b38b-4f9e-9379-3e1484bad8cb12019-06-19
44087-4000-5EA - Each44087-4000ac773474-25f7-4eb0-9141-ba11f361dde112019-06-19
44087-4000-6EA - Each44087-4000ec00c72a-f05e-4b79-8c9c-04799d91e5bd12019-06-19
44087-4000-7EA - Each44087-4000f261a4cd-786d-44ec-b355-b3d05a2e638712019-06-19
44087-4000-8EA - Each44087-4000c769fb6c-e76c-4e9a-81d2-3087ca8ec63512019-06-19
44087-4000-9EA - Each44087-4000032a40c8-0228-44f8-baf2-1288d3acd8a712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-4000MAVENCLAD (CLADRIBINE) TABLET [EMD SERONO, INC.]8Current NDC, Legacy NDC, 14 package rows20240523_9c75e30a-a410-40f1-b653-04d532bd9144.zip

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MavencladCLADRIBINEEMD Serono, Inc.9c75e30a-a410-40f1-b653-04d532bd91442026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022561
application number: NDA022561
ndc (product): 44087-4000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2122661{10 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 10 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122659{4 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 4 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122657{5 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 5 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122655{6 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 6 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122650{7 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 7 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122648{8 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 8 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122642{9 (cladribine 10 MG Oral Tablet [Mavenclad]) } Pack [Mavenclad 9 Tablet Pack]BPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122660{10 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122658{4 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122656{5 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122654{6 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122649{7 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122647{8 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122635{9 (cladribine 10 MG Oral Tablet) } PackGPCK9c75e30a-a410-40f1-b653-04d532bd914410
2122660cladribine 10 MG (10) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122658cladribine 10 MG (4) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122656cladribine 10 MG (5) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122654cladribine 10 MG (6) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122649cladribine 10 MG (7) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122647cladribine 10 MG (8) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122635Cladribine 10 MG (9) Oral Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122634cladribine 10 MG Oral TabletPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122641Mavenclad 10 MG Oral TabletPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122661MAVENCLAD 10 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122659MAVENCLAD 4 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122657MAVENCLAD 5 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122655MAVENCLAD 6 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122650MAVENCLAD 7 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122648MAVENCLAD 8 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122642MAVENCLAD 9 Tablet PackPSN9c75e30a-a410-40f1-b653-04d532bd914410
2122641cladribine 10 MG Oral Tablet [Mavenclad]SBD9c75e30a-a410-40f1-b653-04d532bd914410
2122634cladribine 10 MG Oral TabletSCD9c75e30a-a410-40f1-b653-04d532bd914410
2122641Mavenclad 10 MG Oral TabletSY9c75e30a-a410-40f1-b653-04d532bd914410
2122661Mavenclad 10 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122659Mavenclad 4 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122657Mavenclad 5 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122655Mavenclad 6 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122650Mavenclad 7 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122648Mavenclad 8 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410
2122642Mavenclad 9 Tablet PackSY9c75e30a-a410-40f1-b653-04d532bd914410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-4000-0440874000005 BLISTER PACK in 1 CARTON (44087-4000-0) / 2 TABLET in 1 BLISTER PACK5 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-4440874000044 BLISTER PACK in 1 CARTON (44087-4000-4) / 1 TABLET in 1 BLISTER PACK4 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-5440874000055 BLISTER PACK in 1 CARTON (44087-4000-5) / 1 TABLET in 1 BLISTER PACK5 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-6440874000066 BLISTER PACK in 1 CARTON (44087-4000-6) / 1 TABLET in 1 BLISTER PACK6 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-7440874000077 BLISTER PACK in 1 CARTON (44087-4000-7) / 1 TABLET in 1 BLISTER PACK7 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-8440874000088 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACK8 blister pack2019-04-010000-00-00NoNoCurrent
44087-4000-9440874000099 BLISTER PACK in 1 CARTON (44087-4000-9) / 1 TABLET in 1 BLISTER PACK9 blister pack2019-04-010000-00-00NoNoCurrent