Home Applications 018692 Application 018692
Type NDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MARCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018692-001 MARCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018692-001 AP
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018692-001 MARCAINE 0.75% INJECTABLE / SPINAL AP RLD, RS 1984-05-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-1761 Marcaine Spinal Bupivacaine Hydrochloride in Dextrose Hospira, Inc. NDA Current 0409-1761 Marcaine Spinal Bupivacaine Hydrochloride in Dextrose Hospira, Inc. NDA Current 0409-1761 Marcaine Spinal Bupivacaine Hydrochloride in Dextrose Hospira, Inc. NDA Current 0409-1761 Marcaine Spinal Bupivacaine Hydrochloride in Dextrose Hospira, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72277 SUPPL 2022-10-11 72180 SUPPL 2022-09-29 62271 ORIG 2020-03-24 56348 SUPPL 2018-11-08 56263 SUPPL 2018-11-05 15091 SUPPL 2012-02-01 11278 SUPPL 2012-01-31 11277 SUPPL 2010-02-25 1024 SUPPL 2010-02-25 1023 SUPPL 2003-06-22