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 02:13:56

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0078-61EA - Each0006-00788df8f293-3f4e-418f-89cd-64408a56622d12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0006-00780006-0078-61

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202270-001JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02
N202270-002JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02
N202270-003JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2012-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N202270-001AB
N202270-002AB
N202270-003AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202270-00173267082026-11-24U-1227Drug substance, Drug product
N202270-0017326708*PED2027-05-24Pediatric extension
N202270-00273267082026-11-24U-1227Drug substance, Drug product
N202270-0027326708*PED2027-05-24Pediatric extension
N202270-00373267082026-11-24U-1227Drug substance, Drug product
N202270-0037326708*PED2027-05-24Pediatric extension

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2012-02-0284e616aacf4f…
2026-08-18 06:07:402026-07N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2012-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALRLD, RS2012-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALRLD2012-02-02301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N202270-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N202270-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N202270-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N202270-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N202270-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N202270-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202270-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202270-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202270-003AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 13 · 501 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N202270-00173267082026-11-24U-1227Drug substance, Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202270-0017326708*PED2027-05-24Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N202270-00273267082026-11-24U-1227Drug substance, Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202270-0027326708*PED2027-05-24Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N202270-00373267082026-11-24U-1227Drug substance, Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N202270-0037326708*PED2027-05-24Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N202270-00173267082026-11-24U-1227Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202270-0017326708*PED2027-05-24Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N202270-00273267082026-11-24U-1227Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202270-0027326708*PED2027-05-24Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N202270-00373267082026-11-24U-1227Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N202270-0037326708*PED2027-05-24Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202270-00173267082026-11-24U-1227Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-0017326708*PED2027-05-24Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-00273267082026-11-24U-1227Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-0027326708*PED2027-05-24Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-00373267082026-11-24U-1227Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202270-0037326708*PED2027-05-24Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-00173267082026-11-24U-1227Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-0017326708*PED2027-05-24Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-00273267082026-11-24U-1227Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-0027326708*PED2027-05-24Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-00373267082026-11-24U-1227Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202270-0037326708*PED2027-05-24Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N202270-00173267082026-11-24U-1227Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-0017326708*PED2027-05-24Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-00273267082026-11-24U-1227Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-0027326708*PED2027-05-24Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-00373267082026-11-24U-1227Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202270-0037326708*PED2027-05-24Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-00173267082026-11-24U-1227Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-0017326708*PED2027-05-24Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-00273267082026-11-24U-1227Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-0027326708*PED2027-05-24Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-00373267082026-11-24U-1227Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202270-0037326708*PED2027-05-24Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-00173267082026-11-24U-1227Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-0017326708*PED2027-05-24Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-00273267082026-11-24U-1227Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202270-0027326708*PED2027-05-24Pediatric extensionb8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-001M-1872023-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-001PED2024-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-002M-1872023-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202270-002PED2024-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-001M-1872023-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-001PED2024-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-002M-1872023-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202270-002PED2024-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-001M-1872023-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-001PED2024-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-002M-1872023-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202270-002PED2024-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-001M-1872023-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-001PED2024-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-002M-1872023-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202270-002PED2024-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202270-001M-1872023-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N202270-001PED2024-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N202270-002M-1872023-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N202270-002PED2024-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-001M-1872023-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-001PED2024-06-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-002M-1872023-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202270-002PED2024-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202270-001M-1872023-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202270-001PED2024-06-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202270-002M-1872023-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202270-002PED2024-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202270-001M-1872023-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202270-001PED2024-06-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202270-002M-1872023-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202270-002PED2024-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202270-001M-1872023-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202270-001PED2024-06-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202270-002M-1872023-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202270-002PED2024-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202270-001M-2442022-08-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202270-001PED2023-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202270-001M-1872023-12-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202270-001PED2024-06-045c6f7cd8ea54…

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
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0006-0078-61
ndc11 (package): 00006007861

Reported adverse events (FAERS/openFDA)#

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