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 02:52:24

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65250-266-20ML - Milliliter65250-266d9fc2b4c-b59b-4707-8e69-dc8e5f11ce4512012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65250-26665250-266-20

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
N022496-001EXPARELBUPIVACAINE133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28
N022496-002EXPARELBUPIVACAINE266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022496-001110334952041-01-22U-3182Drug product2021-07-30
N022496-001111793362041-01-22U-3250Drug product2021-11-30
N022496-001112784942041-01-22U-3250Drug product2022-04-04
N022496-001113049042041-01-22U-3346Drug product2022-04-21
N022496-001113114862041-01-22U-3250Drug product2022-04-27
N022496-001113577272041-01-22U-3380Drug product2022-06-16
N022496-001114263482041-01-22U-3380Drug product2022-09-02
N022496-001114526912041-01-22U-3439Drug product2022-10-04
N022496-001118195742041-01-22U-3250Drug product2023-12-06
N022496-001118195752041-01-22U-3250Drug product2023-12-06
N022496-001119257062041-01-22U-3380Drug product2024-03-15
N022496-001121448902041-01-22U-4033Drug product2024-11-20
N022496-001121510242041-01-22U-4037Drug product2024-11-26
N022496-001122960472041-01-22U-4184Drug product2025-05-20
N022496-001119314592042-03-17U-38392024-03-20
N022496-001119314592042-03-17U-38402024-03-20
N022496-001119185652043-02-02U-38412024-03-20
N022496-001122266102043-02-02U-41482025-03-14
N022496-001122266102043-02-02U-41492025-03-14
N022496-001122266102043-02-02U-41502025-03-14
N022496-001121569402044-07-02Drug product2024-12-03
N022496-001122514682044-07-02U-4152Drug product2025-03-21
N022496-001123184832044-07-02U-41522025-06-11
N022496-001123701422044-07-02U-4152Drug product2025-08-07
N022496-002110334952041-01-22U-3182Drug product2021-07-30
N022496-002111793362041-01-22U-3250Drug product2021-11-30
N022496-002112784942041-01-22U-3250Drug product2022-04-04
N022496-002113049042041-01-22U-3346Drug product2022-04-21
N022496-002113114862041-01-22U-3250Drug product2022-04-27
N022496-002113577272041-01-22U-3380Drug product2022-06-16
N022496-002114263482041-01-22U-3380Drug product2022-09-02
N022496-002114526912041-01-22U-3439Drug product2022-10-04
N022496-002118195742041-01-22U-3250Drug product2023-12-06
N022496-002118195752041-01-22U-3250Drug product2023-12-06
N022496-002119257062041-01-22U-3380Drug product2024-03-15
N022496-002121448902041-01-22U-4033Drug product2024-11-20
N022496-002121510242041-01-22U-4037Drug product2024-11-26
N022496-002122960472041-01-22U-4184Drug product2025-05-20
N022496-002119314592042-03-17U-38392024-03-20
N022496-002119314592042-03-17U-38402024-03-20
N022496-002119185652043-02-02U-38412024-03-20
N022496-002122266102043-02-02U-41482025-03-14
N022496-002122266102043-02-02U-41492025-03-14
N022496-002122266102043-02-02U-41502025-03-14
N022496-002121569402044-07-02Drug product2024-12-03
N022496-002122514682044-07-02U-4152Drug product2025-03-21
N022496-002123184832044-07-02U-41522025-06-11
N022496-002123701422044-07-02U-4152Drug product2025-08-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N022496-001I-9292026-11-09
N022496-002I-9292026-11-09

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 22:38:342026-08N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2884e616aacf4f…
2026-09-14 22:38:342026-08N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2884e616aacf4f…
2026-08-18 06:07:402026-07N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONAPRLD, RS2011-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022496-001EXPAREL133MG/10ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022496-002EXPAREL266MG/20ML (13.3MG/ML)INJECTABLE, LIPOSOMAL / INJECTIONRLD, RS2011-10-2874a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N022496-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022496-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022496-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022496-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022496-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022496-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022496-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022496-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022496-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022496-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022496-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022496-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022496-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022496-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022496-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022496-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022496-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022496-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022496-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022496-002AP1301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 22 · 874 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022496-001110334952041-01-22U-3182Drug product2021-07-3084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001111793362041-01-22U-3250Drug product2021-11-3084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001112784942041-01-22U-3250Drug product2022-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N022496-001113049042041-01-22U-3346Drug product2022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022496-001113114862041-01-22U-3250Drug product2022-04-2784e616aacf4f…
2026-09-14 22:38:342026-08N022496-001113577272041-01-22U-3380Drug product2022-06-1684e616aacf4f…
2026-09-14 22:38:342026-08N022496-001114263482041-01-22U-3380Drug product2022-09-0284e616aacf4f…
2026-09-14 22:38:342026-08N022496-001114526912041-01-22U-3439Drug product2022-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N022496-001118195742041-01-22U-3250Drug product2023-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N022496-001118195752041-01-22U-3250Drug product2023-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N022496-001119257062041-01-22U-3380Drug product2024-03-1584e616aacf4f…
2026-09-14 22:38:342026-08N022496-001121448902041-01-22U-4033Drug product2024-11-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001121510242041-01-22U-4037Drug product2024-11-2684e616aacf4f…
2026-09-14 22:38:342026-08N022496-001122960472041-01-22U-4184Drug product2025-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001119314592042-03-17U-38392024-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001119314592042-03-17U-38402024-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001119185652043-02-02U-38412024-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-001122266102043-02-02U-41482025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022496-001122266102043-02-02U-41492025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022496-001122266102043-02-02U-41502025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022496-001121569402044-07-02Drug product2024-12-0384e616aacf4f…
2026-09-14 22:38:342026-08N022496-001122514682044-07-02U-4152Drug product2025-03-2184e616aacf4f…
2026-09-14 22:38:342026-08N022496-001123184832044-07-02U-41522025-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N022496-001123701422044-07-02U-4152Drug product2025-08-0784e616aacf4f…
2026-09-14 22:38:342026-08N022496-002110334952041-01-22U-3182Drug product2021-07-3084e616aacf4f…
2026-09-14 22:38:342026-08N022496-002111793362041-01-22U-3250Drug product2021-11-3084e616aacf4f…
2026-09-14 22:38:342026-08N022496-002112784942041-01-22U-3250Drug product2022-04-0484e616aacf4f…
2026-09-14 22:38:342026-08N022496-002113049042041-01-22U-3346Drug product2022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022496-002113114862041-01-22U-3250Drug product2022-04-2784e616aacf4f…
2026-09-14 22:38:342026-08N022496-002113577272041-01-22U-3380Drug product2022-06-1684e616aacf4f…
2026-09-14 22:38:342026-08N022496-002114263482041-01-22U-3380Drug product2022-09-0284e616aacf4f…
2026-09-14 22:38:342026-08N022496-002114526912041-01-22U-3439Drug product2022-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N022496-002118195742041-01-22U-3250Drug product2023-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N022496-002118195752041-01-22U-3250Drug product2023-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N022496-002119257062041-01-22U-3380Drug product2024-03-1584e616aacf4f…
2026-09-14 22:38:342026-08N022496-002121448902041-01-22U-4033Drug product2024-11-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-002121510242041-01-22U-4037Drug product2024-11-2684e616aacf4f…
2026-09-14 22:38:342026-08N022496-002122960472041-01-22U-4184Drug product2025-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-002119314592042-03-17U-38402024-03-2084e616aacf4f…
2026-09-14 22:38:342026-08N022496-002119314592042-03-17U-38392024-03-2084e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N022496-001I-9292026-11-0984e616aacf4f…
2026-09-14 22:38:342026-08N022496-002I-9292026-11-0984e616aacf4f…
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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
EXPARELBUPIVACAINEPacira Pharmaceuticals, Inc.bb5a9e59-0f51-11df-8a39-0800200c9a662025-12-12Warnings, Adverse reactionsExact identifier
ndc (package): 65250-266-20
ndc11 (package): 65250026620

Reported adverse events (FAERS/openFDA)#

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