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 01:54:32

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-0600-10EA - Each0456-060060b6dd6d-7ea2-467e-bc52-657d9a5706b512012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0456-06000456-0600-10

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
N200327-001TEFLAROCEFTAROLINE FOSAMIL400MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29
N200327-002TEFLAROCEFTAROLINE FOSAMIL600MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N200327-001AP
N200327-002AP

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N200327-00196298612030-09-21Drug product2017-05-17
N200327-00182474002031-02-10U-282Drug product
N200327-00296298612030-09-21Drug product2017-05-17
N200327-00282474002031-02-10U-282Drug 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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-2984e616aacf4f…
2026-09-14 22:38:342026-08N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-2984e616aacf4f…
2026-08-18 06:07:402026-07N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSAPRLD, RS2010-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N200327-001TEFLARO400MG/VIALPOWDER / INTRAVENOUSRLD2010-10-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200327-002TEFLARO600MG/VIALPOWDER / INTRAVENOUSRLD, RS2010-10-2974a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N200327-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N200327-002AP184e616aacf4f…
2026-08-18 06:07:402026-07N200327-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N200327-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N200327-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200327-002AP1011fe1cb6892…
2022-04-04 05:41 UTC2022-04N200327-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N200327-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N200327-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N200327-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N200327-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N200327-002AP1782e0a99824c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N200327-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N200327-002AP1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 7 · 244 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N200327-00196298612030-09-21Drug product2017-05-1784e616aacf4f…
2026-09-14 22:38:342026-08N200327-00182474002031-02-10U-282Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N200327-00296298612030-09-21Drug product2017-05-1784e616aacf4f…
2026-09-14 22:38:342026-08N200327-00282474002031-02-10U-282Drug product84e616aacf4f…
2026-08-18 06:07:402026-07N200327-00196298612030-09-21Drug product2017-05-17caaa826d4ba7…
2026-08-18 06:07:402026-07N200327-00182474002031-02-10U-282Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N200327-00296298612030-09-21Drug product2017-05-17caaa826d4ba7…
2026-08-18 06:07:402026-07N200327-00282474002031-02-10U-282Drug productcaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N200327-00196298612030-09-21Drug product2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200327-00182474002031-02-10U-282Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200327-00296298612030-09-21Drug product2017-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N200327-00282474002031-02-10U-282Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-00196298612030-09-21Drug product2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-00182474002031-02-10U-282Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-00296298612030-09-21Drug product2017-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N200327-00282474002031-02-10U-282Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N200327-00196298612030-09-21Drug product2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200327-00182474002031-02-10U-282Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200327-00296298612030-09-21Drug product2017-05-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N200327-00282474002031-02-10U-282Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-00196298612030-09-21Drug product2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-00182474002031-02-10U-282Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-00296298612030-09-21Drug product2017-05-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N200327-00282474002031-02-10U-282Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-00196298612030-09-21Drug product2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-00182474002031-02-10U-282Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-00296298612030-09-21Drug product2017-05-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N200327-00282474002031-02-10U-282Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-00196298612030-09-21Drug product2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-00182474002031-02-10U-282Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-00296298612030-09-21Drug product2017-05-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N200327-00282474002031-02-10U-282Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-00196298612030-09-21Drug product2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-00182474002031-02-10U-282Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-00296298612030-09-21Drug product2017-05-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N200327-00282474002031-02-10U-282Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-00196298612030-09-21Drug product2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-00182474002031-02-10U-282Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-00296298612030-09-21Drug product2017-05-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N200327-00282474002031-02-10U-282Drug product5bbf6a4d5a75…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200327-001NPP2022-09-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N200327-002NPP2022-09-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N200327-001NPP2022-09-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N200327-002NPP2022-09-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N200327-001NPP2022-09-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N200327-002NPP2022-09-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N200327-001NPP2019-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200327-001NPP2019-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200327-002NPP2019-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N200327-002NPP2019-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N200327-001NPP2022-09-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N200327-002NPP2022-09-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N200327-001NPP2022-09-13782e0a99824c…
2021-12-28 21:50 UTC2021-12N200327-002NPP2022-09-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N200327-001NPP2022-09-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N200327-002NPP2022-09-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N200327-001NPP2022-09-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N200327-002NPP2022-09-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N200327-001NPP2022-09-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N200327-002NPP2022-09-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N200327-001NPP2022-09-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N200327-002NPP2022-09-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N200327-001NPP2019-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N200327-001NPP2019-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N200327-002NPP2019-05-273f01610625f2…
2019-12-14 00:12 UTC2019-12N200327-002NPP2019-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09N200327-001NPP2019-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N200327-001NPP2019-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N200327-002NPP2019-05-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N200327-002NPP2019-05-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N200327-001NPP2019-05-27ea99ee380514…
2019-07-19 19:46 UTC2019-07N200327-001NPP2019-05-27ea99ee380514…
2019-07-19 19:46 UTC2019-07N200327-002NPP2019-05-27ea99ee380514…
2019-07-19 19:46 UTC2019-07N200327-002NPP2019-05-27ea99ee380514…
2023-01-26 05:58 UTC2023-01N200327-001NPP2022-09-133bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N200327-002NPP2022-09-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N200327-001NPP2022-09-133a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N200327-002NPP2022-09-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N200327-001NPP2022-09-13f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N200327-002NPP2022-09-13f41ea6bd6efb…

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
TeflaroCEFTAROLINE FOSAMILAllergan, Inc.3ecde48b-75a2-4beb-9999-369f3f61bb8a2024-11-20Warnings, Adverse reactionsExact identifier
ndc (package): 0456-0600-10
ndc11 (package): 00456060010

Reported adverse events (FAERS/openFDA)#

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