National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2013-04-01
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 04:04:36

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0634-61ML - Milliliter0078-063471fef68e-ff8f-4dee-a003-0bbc1b3d4c3a12013-04-01

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0078-06340078-0634-61

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
N200677-001SIGNIFORPASIREOTIDE DIASPARTATEEQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14
N200677-002SIGNIFORPASIREOTIDE DIASPARTATEEQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14
N200677-003SIGNIFORPASIREOTIDE DIASPARTATEEQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N200677-00174737612026-12-14Drug substance, Drug product2013-01-10
N200677-00274737612026-12-14Drug substance, Drug product2013-01-10
N200677-00374737612026-12-14Drug substance, Drug product2013-01-10

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 22:38:342026-08N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1484e616aacf4f…
2026-09-14 22:38:342026-08N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1484e616aacf4f…
2026-09-14 22:38:342026-08N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-1484e616aacf4f…
2026-08-18 06:07:402026-07N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14caaa826d4ba7…
2026-08-18 06:07:402026-07N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200677-002SIGNIFOREQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200677-003SIGNIFOREQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2012-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N200677-001SIGNIFOREQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD2012-12-14301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N200677-00174737612026-12-14Drug substance, Drug product2013-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N200677-00274737612026-12-14Drug substance, Drug product2013-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N200677-00374737612026-12-14Drug substance, Drug product2013-01-1084e616aacf4f…
2026-08-18 06:07:402026-07N200677-00174737612026-12-14Drug substance, Drug product2013-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N200677-00274737612026-12-14Drug substance, Drug product2013-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N200677-00374737612026-12-14Drug substance, Drug product2013-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N200677-00174737612026-12-14Drug substance, Drug product2013-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200677-00274737612026-12-14Drug substance, Drug product2013-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200677-00374737612026-12-14Drug substance, Drug product2013-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00182992092025-12-27Drug substance, Drug product2013-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00174737612026-12-14Drug substance, Drug product2013-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00282992092025-12-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00274737612026-12-14Drug substance, Drug product2013-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00382992092025-12-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200677-00374737612026-12-14Drug substance, Drug product2013-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N200677-00182992092025-12-27Drug substance, Drug product2013-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-00174737612026-12-14Drug substance, Drug product2013-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-00282992092025-12-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-00274737612026-12-14Drug substance, Drug product2013-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-00382992092025-12-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200677-00374737612026-12-14Drug substance, Drug product2013-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00182992092025-12-27Drug substance, Drug product2013-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00174737612026-12-14Drug substance, Drug product2013-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00282992092025-12-27Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00274737612026-12-14Drug substance, Drug product2013-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00382992092025-12-27Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200677-00374737612026-12-14Drug substance, Drug product2013-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00182992092025-12-27Drug substance, Drug product2013-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00174737612026-12-14Drug substance, Drug product2013-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00282992092025-12-27Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00274737612026-12-14Drug substance, Drug product2013-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00382992092025-12-27Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200677-00374737612026-12-14Drug substance, Drug product2013-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00182992092025-12-27Drug substance, Drug product2013-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00174737612026-12-14Drug substance, Drug product2013-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00282992092025-12-27Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00274737612026-12-14Drug substance, Drug product2013-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00382992092025-12-27Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200677-00374737612026-12-14Drug substance, Drug product2013-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200677-00182992092025-12-27Drug substance, Drug product2013-01-102680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N200677-001ODE-342019-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200677-002ODE-342019-12-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200677-003ODE-342019-12-1474a2ff9319b5…
2019-12-14 00:12 UTC2019-12N200677-001ODE-342019-12-143f01610625f2…
2019-12-14 00:12 UTC2019-12N200677-002ODE-342019-12-143f01610625f2…
2019-12-14 00:12 UTC2019-12N200677-003ODE-342019-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09N200677-001ODE-342019-12-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N200677-002ODE-342019-12-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N200677-003ODE-342019-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N200677-001ODE-342019-12-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N200677-002ODE-342019-12-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N200677-003ODE-342019-12-14ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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