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 02:00:06

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-840-02EA - Each50458-8406c41e9b4-e311-4eb1-8a81-e4a05b7c7fef12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50458-84050458-840-02

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
N022304-001NUCYNTATAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET / ORALABRLD2008-11-20
N022304-002NUCYNTATAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET / ORALABRLD2008-11-20
N022304-003NUCYNTATAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRLD, RS2008-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022304-001AB
N022304-002AB
N022304-003AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N022304-001NPP2026-07-03
N022304-001PED2027-01-03
N022304-002NPP2026-07-03
N022304-002PED2027-01-03
N022304-003NPP2026-07-03
N022304-003PED2027-01-03

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 22:38:342026-08N022304-001NUCYNTAEQ 50MG BASETABLET / ORALABRLD2008-11-2084e616aacf4f…
2026-09-14 22:38:342026-08N022304-002NUCYNTAEQ 75MG BASETABLET / ORALABRLD2008-11-2084e616aacf4f…
2026-09-14 22:38:342026-08N022304-003NUCYNTAEQ 100MG BASETABLET / ORALABRLD, RS2008-11-2084e616aacf4f…
2026-08-18 06:07:402026-07N022304-001NUCYNTAEQ 50MG BASETABLET / ORALABRLD2008-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-002NUCYNTAEQ 75MG BASETABLET / ORALABRLD2008-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-003NUCYNTAEQ 100MG BASETABLET / ORALABRLD, RS2008-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022304-001NUCYNTAEQ 50MG BASETABLET / ORALABRLD2008-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002NUCYNTAEQ 75MG BASETABLET / ORALABRLD2008-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003NUCYNTAEQ 100MG BASETABLET / ORALABRLD, RS2008-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-002NUCYNTAEQ 75MG BASETABLET / ORALRLD2008-11-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022304-003NUCYNTAEQ 100MG BASETABLET / ORALRLD, RS2008-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022304-001NUCYNTAEQ 50MG BASETABLET / ORALRLD2008-11-20301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022304-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022304-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N022304-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N022304-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022304-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022304-003AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0017994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00279943642025-06-27U-931Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0027994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-00379943642025-06-27U-931Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-0037994364*PED2025-12-27Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0017994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-00279943642025-06-27U-931Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0027994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-00379943642025-06-27U-931Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-0037994364*PED2025-12-27Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0017994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00279943642025-06-27U-931Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0027994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-00379943642025-06-27U-931Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-0037994364*PED2025-12-27Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0017994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00279943642025-06-27U-931Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0027994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-00379943642025-06-27U-931Drug substance, Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-0037994364*PED2025-12-27Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0017994364*PED2025-12-27Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00279943642025-06-27U-931Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0027994364*PED2025-12-27Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-00379943642025-06-27U-931Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022304-0037994364*PED2025-12-27Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0017994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00279943642025-06-27U-931Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0027994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-00379943642025-06-27U-931Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022304-0037994364*PED2025-12-27Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-00179943642025-06-27U-931Drug substance, Drug product2011-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-0017994364*PED2025-12-27Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-00279943642025-06-27U-931Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022304-0027994364*PED2025-12-27Pediatric extension5bbf6a4d5a75…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N022304-001NPP2026-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N022304-001PED2027-01-0384e616aacf4f…
2026-09-14 22:38:342026-08N022304-002NPP2026-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N022304-002PED2027-01-0384e616aacf4f…
2026-09-14 22:38:342026-08N022304-003NPP2026-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N022304-003PED2027-01-0384e616aacf4f…
2026-08-18 06:07:402026-07N022304-001NPP2026-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-001PED2027-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-002NPP2026-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-002PED2027-01-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-003NPP2026-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N022304-003PED2027-01-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022304-001NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-001PED2027-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-002PED2027-01-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003NPP2026-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022304-003PED2027-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-001PED2027-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-002PED2027-01-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003NPP2026-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022304-003PED2027-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022304-001NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-001PED2027-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-002PED2027-01-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003NPP2026-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022304-003PED2027-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-001PED2027-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-002PED2027-01-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003NPP2026-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022304-003PED2027-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001NPP2026-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-001PED2027-01-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002NPP2026-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022304-002PED2027-01-03b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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