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 01:48:30

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-633-56EA - Each21695-633523c606e-2f3a-48bf-b80b-2f335cf0bace12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-63321695-633-56

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021928-001CHANTIXVARENICLINE TARTRATEEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10
N021928-002CHANTIXVARENICLINE TARTRATEEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021928-001AB
N021928-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1084e616aacf4f…
2026-09-14 22:38:342026-08N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1084e616aacf4f…
2026-08-18 06:07:402026-07N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALRLD2006-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002CHANTIXEQ 1MG BASETABLET / ORALRLD2006-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD2006-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD2006-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALRLD2006-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002CHANTIXEQ 1MG BASETABLET / ORALRLD, RS2006-05-1074a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021928-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021928-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N021928-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021928-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021928-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021928-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-002AB131067a03dcf5…
2022-04-08 23:34 UTC2022-04N021928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021928-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021928-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002AB1782e0a99824c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021928-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021928-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00168909272022-05-06U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00172651192022-08-03U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0016890927*PED2022-11-06Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0017265119*PED2023-02-03Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00268909272022-05-06U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00272651192022-08-03U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0026890927*PED2022-11-06Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0027265119*PED2023-02-03Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-00168909272022-05-06U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00172651192022-08-03U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0016890927*PED2022-11-06Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0017265119*PED2023-02-03Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00268909272022-05-06U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00272651192022-08-03U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0026890927*PED2022-11-06Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0027265119*PED2023-02-03Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-00168909272022-05-06U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00172651192022-08-03U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0016890927*PED2022-11-06Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0017265119*PED2023-02-03Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00268909272022-05-06U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00272651192022-08-03U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0026890927*PED2022-11-06Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0027265119*PED2023-02-03Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-00164105502020-05-10U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0016410550*PED2020-11-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00168909272022-05-06U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00172651192022-08-03U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0016890927*PED2022-11-06Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0017265119*PED2023-02-03Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00264105502020-05-10U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0026410550*PED2020-11-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00268909272022-05-06U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00272651192022-08-03U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0026890927*PED2022-11-06Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0027265119*PED2023-02-03Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021928-00168909272022-05-06U-56Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-00172651192022-08-03U-56Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-0016890927*PED2022-11-06Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-0017265119*PED2023-02-03Pediatric extensionbb7c543d1eb4…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001M-2372022-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001PED2022-08-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002M-2372022-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002PED2022-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-001M-2372022-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-001PED2022-08-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002M-2372022-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002PED2022-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001M-2372022-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-001PED2022-08-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002M-2372022-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002PED2022-08-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-001M-1832019-08-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001M-1922019-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2020-02-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2020-06-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001M-2372022-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2022-08-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-1832019-08-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-1922019-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2020-02-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2020-06-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-2372022-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2022-08-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021928-001M-2372022-02-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-001PED2022-08-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002M-2372022-02-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002PED2022-08-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021928-001M-2372022-02-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-001PED2022-08-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002M-2372022-02-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002PED2022-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-001M-2372022-02-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-001PED2022-08-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-002M-2372022-02-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-002PED2022-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N021928-001M-2372022-02-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-001PED2022-08-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-002M-2372022-02-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-002PED2022-08-225aa47cf7b7d7…

Reported adverse events (FAERS/openFDA)#

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