National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2013-05-02
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 04:08:46

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-005-01EA - Each64406-005f66b69e7-ec0c-4a86-bd4f-465bc9d06c6012013-05-02

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64406-00564406-005-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N204063-001TECFIDERADIMETHYL FUMARATE120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27
N204063-002TECFIDERADIMETHYL FUMARATE240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N204063-001AB
N204063-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204063-00183995142028-02-07U-13842013-04-24
N204063-001103911602035-03-13U-31482021-04-28
N204063-001105559932035-03-13U-31482021-04-28
N204063-001109940032035-03-13U-31482021-05-28
N204063-001109599722035-11-16U-13842021-04-28
N204063-001110071662035-11-16U-13842021-05-28
N204063-001110071672035-11-16U-13842021-05-28
N204063-001111298062035-11-16U-13842021-10-27
N204063-001112468502035-11-16U-13842022-03-11
N204063-00283995142028-02-07U-13842013-04-24
N204063-002103911602035-03-13U-31482021-04-28
N204063-002105559932035-03-13U-31482021-04-28
N204063-002109940032035-03-13U-31482021-05-28
N204063-002109599722035-11-16U-13842021-04-28
N204063-002110071662035-11-16U-13842021-05-28
N204063-002110071672035-11-16U-13842021-05-28
N204063-002111298062035-11-16U-13842021-10-27
N204063-002112468502035-11-16U-13842022-03-11

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-2784e616aacf4f…
2026-09-14 22:38:342026-08N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-2784e616aacf4f…
2026-08-18 06:07:402026-07N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALABRLD2013-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALABRLD, RS2013-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204063-001TECFIDERA120MGCAPSULE, DELAYED RELEASE / ORALRLD2013-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204063-002TECFIDERA240MGCAPSULE, DELAYED RELEASE / ORALRLD, RS2013-03-2774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N204063-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N204063-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N204063-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204063-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204063-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204063-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204063-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204063-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204063-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204063-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204063-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204063-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204063-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204063-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204063-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204063-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204063-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204063-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204063-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204063-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204063-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204063-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N204063-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204063-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204063-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204063-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204063-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204063-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204063-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204063-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204063-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204063-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204063-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204063-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204063-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204063-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204063-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N204063-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204063-002AB1bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 17 · 676 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N204063-00183995142028-02-07U-13842013-04-2484e616aacf4f…
2026-09-14 22:38:342026-08N204063-001103911602035-03-13U-31482021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001105559932035-03-13U-31482021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001109940032035-03-13U-31482021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001109599722035-11-16U-13842021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001110071662035-11-16U-13842021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001110071672035-11-16U-13842021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-001111298062035-11-16U-13842021-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N204063-001112468502035-11-16U-13842022-03-1184e616aacf4f…
2026-09-14 22:38:342026-08N204063-00283995142028-02-07U-13842013-04-2484e616aacf4f…
2026-09-14 22:38:342026-08N204063-002103911602035-03-13U-31482021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002105559932035-03-13U-31482021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002109940032035-03-13U-31482021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002109599722035-11-16U-13842021-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002110071662035-11-16U-13842021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002110071672035-11-16U-13842021-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N204063-002111298062035-11-16U-13842021-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N204063-002112468502035-11-16U-13842022-03-1184e616aacf4f…
2026-08-18 06:07:402026-07N204063-00183995142028-02-07U-13842013-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001103911602035-03-13U-31482021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001105559932035-03-13U-31482021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001109940032035-03-13U-31482021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001109599722035-11-16U-13842021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001110071662035-11-16U-13842021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001110071672035-11-16U-13842021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001111298062035-11-16U-13842021-10-27caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-001112468502035-11-16U-13842022-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-00283995142028-02-07U-13842013-04-24caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002103911602035-03-13U-31482021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002105559932035-03-13U-31482021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002109940032035-03-13U-31482021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002109599722035-11-16U-13842021-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002110071662035-11-16U-13842021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002110071672035-11-16U-13842021-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002111298062035-11-16U-13842021-10-27caaa826d4ba7…
2026-08-18 06:07:402026-07N204063-002112468502035-11-16U-13842022-03-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204063-00183995142028-02-07U-13842013-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204063-001103911602035-03-13U-31482021-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204063-001105559932035-03-13U-31482021-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204063-001109940032035-03-13U-31482021-05-28011fe1cb6892…

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 ZIP2022-06N204063-001M-2602023-02-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204063-002M-2602023-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204063-001M-2602023-02-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204063-002M-2602023-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204063-001M-2602023-02-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204063-002M-2602023-02-054b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N204063-001M-2602023-02-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204063-002M-2602023-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204063-001M-2602023-02-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N204063-002M-2602023-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204063-001M-2602023-02-0587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204063-002M-2602023-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N204063-001M-2602023-02-055aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N204063-002M-2602023-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204063-001M-2602023-02-058869cabd3fbd…
2020-12-22 03:56 UTC2020-12N204063-002M-2602023-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204063-001M-2602023-02-05c0c555d07b60…
2020-11-12 02:37 UTC2020-11N204063-002M-2602023-02-05c0c555d07b60…
2023-12-20 04:57 UTC2023-12N204063-001M-2602023-02-05ea1830bbd6c7…
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2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204063-001M-2602023-02-053f0d92c62455…
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2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204063-002M-2602023-02-053a93d1ddd44b…
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2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N204063-002M-2602023-02-05cb3db0bc1861…

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
TECFIDERADIMETHYL FUMARATEBiogen Inc.665d7e74-036c-5f68-5b67-ab84b9b491512025-06-04Warnings, Adverse reactionsExact identifier
ndc (package): 64406-005-01
ndc11 (package): 64406000501

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.