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 03:12:25

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6078-46ML - Milliliter0781-6078fc2abb94-e540-4a5a-93d1-dfdc1088dd8f12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0781-60780781-6078-46

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
A065337-001CEFDINIRCEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06
A065337-002CEFDINIRCEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065337-001AB
A065337-002AB

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 22:38:342026-08A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065337-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065337-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065337-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065337-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065337-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065337-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065337-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065337-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065337-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065337-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065337-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065337-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065337-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065337-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065337-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065337-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065337-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065337-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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