National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 02:45:36

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0140-30EA - Each0597-0140ea14afe5-22bd-4b0a-bc02-88bccfca4be612012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0597-01400597-0140-30

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201280-001TRADJENTALINAGLIPTIN5MGTABLET / ORALABRLD, RS2011-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N201280-001AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201280-00188838052025-11-26Drug product2014-12-09
N201280-0018883805*PED2026-05-26Pediatric extension
N201280-001110335522027-05-04Drug product2021-07-09
N201280-001121788192027-05-04Drug product2025-01-24
N201280-00186739272027-05-04U-1503Delist requested2014-04-15
N201280-00111033552*PED2027-11-04Pediatric extension
N201280-0018673927*PED2027-11-04Pediatric extension
N201280-001100348772029-08-05U-23472018-08-10
N201280-00194865262029-08-05U-19152016-11-18
N201280-00110034877*PED2030-02-05Pediatric extension
N201280-0019486526*PED2030-02-05Pediatric extension
N201280-001119113882030-04-10U-38542024-03-25
N201280-00188466952030-06-04U-1503Delist requested2014-10-21
N201280-0018846695*PED2030-12-04Pediatric extension
N201280-00188531562031-03-05U-1642Drug product2015-01-23
N201280-0018853156*PED2031-09-05Pediatric extension
N201280-001123647002037-06-08U-42242025-07-31
N201280-00112364700*PED2037-12-08Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N201280-001M-2952026-06-20
N201280-001PED2026-12-20

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-0284e616aacf4f…
2026-08-18 06:07:402026-07N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N201280-001TRADJENTA5MGTABLET / ORALRLD, RS2011-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N201280-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N201280-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201280-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201280-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N201280-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201280-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201280-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201280-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201280-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201280-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201280-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201280-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201280-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201280-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201280-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201280-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201280-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201280-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201280-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N201280-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201280-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201280-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201280-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201280-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201280-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201280-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201280-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201280-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N201280-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N201280-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201280-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201280-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N201280-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N201280-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N201280-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 19 · 724 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N201280-00188838052025-11-26Drug product2014-12-0984e616aacf4f…
2026-09-14 22:38:342026-08N201280-0018883805*PED2026-05-26Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-001110335522027-05-04Drug product2021-07-0984e616aacf4f…
2026-09-14 22:38:342026-08N201280-001121788192027-05-04Drug product2025-01-2484e616aacf4f…
2026-09-14 22:38:342026-08N201280-00186739272027-05-04U-1503Delist requested2014-04-1584e616aacf4f…
2026-09-14 22:38:342026-08N201280-00111033552*PED2027-11-04Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-0018673927*PED2027-11-04Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-001100348772029-08-05U-23472018-08-1084e616aacf4f…
2026-09-14 22:38:342026-08N201280-00194865262029-08-05U-19152016-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N201280-00110034877*PED2030-02-05Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-0019486526*PED2030-02-05Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-001119113882030-04-10U-38542024-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N201280-00188466952030-06-04U-1503Delist requested2014-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N201280-0018846695*PED2030-12-04Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-00188531562031-03-05U-1642Drug product2015-01-2384e616aacf4f…
2026-09-14 22:38:342026-08N201280-0018853156*PED2031-09-05Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N201280-001123647002037-06-08U-42242025-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N201280-00112364700*PED2037-12-08Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N201280-00188838052025-11-26Drug product2014-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-0018883805*PED2026-05-26Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001110335522027-05-04Drug product2021-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001121788192027-05-04Drug product2025-01-24caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00186739272027-05-04U-1503Delist requested2014-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00111033552*PED2027-11-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-0018673927*PED2027-11-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001100348772029-08-05U-23472018-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00194865262029-08-05U-19152016-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00110034877*PED2030-02-05Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-0019486526*PED2030-02-05Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001119113882030-04-10U-38542024-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00188466952030-06-04U-1503Delist requested2014-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-0018846695*PED2030-12-04Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00188531562031-03-05U-1642Drug product2015-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-0018853156*PED2031-09-05Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001123647002037-06-08U-42242025-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-00112364700*PED2037-12-08Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201280-00188838052025-11-26Drug product2014-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201280-0018883805*PED2026-05-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201280-001110335522027-05-04Drug product2021-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201280-001121788192027-05-04Drug product2025-01-24011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N201280-001M-2952026-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N201280-001PED2026-12-2084e616aacf4f…
2026-08-18 06:07:402026-07N201280-001M-2952026-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N201280-001PED2026-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201280-001M-2952026-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201280-001PED2026-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201280-001M-2952026-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201280-001PED2026-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N201280-001M-2952026-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201280-001PED2026-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201280-001M-2952026-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201280-001PED2026-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201280-001M-2952026-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201280-001PED2026-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201280-001M-2952026-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201280-001PED2026-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201280-001M-2952026-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201280-001PED2026-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201280-001M-2952026-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201280-001PED2026-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201280-001M-2952026-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201280-001PED2026-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201280-001M-2952026-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N201280-001PED2026-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201280-001M-2952026-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201280-001PED2026-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201280-001M-2952026-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201280-001PED2026-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201280-001M-2952026-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201280-001PED2026-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201280-001M-2952026-06-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201280-001PED2026-12-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201280-001M-2582022-07-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201280-001M-2522023-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201280-001M-2582022-07-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201280-001M-2522023-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201280-001M-2582022-07-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201280-001M-2522023-03-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N201280-001M-2582022-07-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N201280-001M-2522023-03-30bb7c543d1eb4…

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
TradjentaLINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.c797ea5c-cab7-494b-9044-27eba0cfe40f2025-03-21Warnings, Adverse reactionsExact identifier
ndc (package): 0597-0140-30
ndc11 (package): 00597014030

Reported adverse events (FAERS/openFDA)#

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