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 01:43:35

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12496-1208-1EA - Each12496-12084cdecec6-4c34-433a-9396-55d69bd2131d12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12496-120812496-1208-1

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022410-001SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30
N022410-002SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30
N022410-003SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-10
N022410-004SUBOXONEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N022410-001AB
N022410-002AB
N022410-003AB
N022410-004AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022410-001111352162029-08-07U-3111Drug product2021-10-21
N022410-00196874542029-08-07U-1464Drug product2017-07-14
N022410-00184758322030-03-26U-1411Drug product2013-07-03
N022410-002111352162029-08-07U-3111Drug product2021-10-21
N022410-00296874542029-08-07U-1464Drug product2017-07-14
N022410-00284758322030-03-26U-1411Drug product
N022410-003111352162029-08-07U-3111Drug product2021-10-21
N022410-00396874542029-08-07U-1464Drug product2017-07-14
N022410-00384758322030-03-26U-1411Drug product
N022410-004111352162029-08-07U-3111Drug product2021-10-21
N022410-00496874542029-08-07U-1464Drug product2017-07-14
N022410-00484758322030-03-26U-1411Drug product

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3084e616aacf4f…
2026-09-14 22:38:342026-08N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-1084e616aacf4f…
2026-09-14 22:38:342026-08N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-1084e616aacf4f…
2026-08-18 06:07:402026-07N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-001SUBOXONEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-002SUBOXONEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALABRLD2010-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-003SUBOXONEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALABRLD2012-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-004SUBOXONEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALABRLD, RS2012-08-105bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022410-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022410-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N022410-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N022410-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N022410-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022410-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022410-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022410-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022410-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022410-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022410-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022410-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022410-004AB15bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 24 · 936 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022410-001111352162029-08-07U-3111Drug product2021-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N022410-00196874542029-08-07U-1464Drug product2017-07-1484e616aacf4f…
2026-09-14 22:38:342026-08N022410-00184758322030-03-26U-1411Drug product2013-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N022410-002111352162029-08-07U-3111Drug product2021-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N022410-00296874542029-08-07U-1464Drug product2017-07-1484e616aacf4f…
2026-09-14 22:38:342026-08N022410-00284758322030-03-26U-1411Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022410-003111352162029-08-07U-3111Drug product2021-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N022410-00396874542029-08-07U-1464Drug product2017-07-1484e616aacf4f…
2026-09-14 22:38:342026-08N022410-00384758322030-03-26U-1411Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022410-004111352162029-08-07U-3111Drug product2021-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N022410-00496874542029-08-07U-1464Drug product2017-07-1484e616aacf4f…
2026-09-14 22:38:342026-08N022410-00484758322030-03-26U-1411Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N022410-001111352162029-08-07U-3111Drug product2021-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00196874542029-08-07U-1464Drug product2017-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00184758322030-03-26U-1411Drug product2013-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-002111352162029-08-07U-3111Drug product2021-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00296874542029-08-07U-1464Drug product2017-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00284758322030-03-26U-1411Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022410-003111352162029-08-07U-3111Drug product2021-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00396874542029-08-07U-1464Drug product2017-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00384758322030-03-26U-1411Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022410-004111352162029-08-07U-3111Drug product2021-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00496874542029-08-07U-1464Drug product2017-07-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022410-00484758322030-03-26U-1411Drug productcaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022410-001111352162029-08-07U-3111Drug product2021-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00196874542029-08-07U-1464Drug product2017-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00184758322030-03-26U-1411Drug product2013-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-002111352162029-08-07U-3111Drug product2021-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00296874542029-08-07U-1464Drug product2017-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00284758322030-03-26U-1411Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-003111352162029-08-07U-3111Drug product2021-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00396874542029-08-07U-1464Drug product2017-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00384758322030-03-26U-1411Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-004111352162029-08-07U-3111Drug product2021-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00496874542029-08-07U-1464Drug product2017-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022410-00484758322030-03-26U-1411Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-001111352162029-08-07U-3111Drug product2021-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-00196874542029-08-07U-1464Drug product2017-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-00184758322030-03-26U-1411Drug product2013-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022410-002111352162029-08-07U-3111Drug product2021-10-2131067a03dcf5…

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
SuboxoneBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEINDIVIOR INC.8a5edcf9-828c-4f97-b671-268ab13a8ecd2025-12-22Warnings, Adverse reactionsExact identifier
ndc (package): 12496-1208-1
ndc11 (package): 12496120801

Reported adverse events (FAERS/openFDA)#

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