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 1.

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.

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
2026-08-01 22:54:32	2026-06	N018692-001	MARCAINE	0.75%	INJECTABLE / SPINAL	AP	RLD, RS	1984-05-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N018692-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Marcaine Spinal	BUPIVACAINE HYDROCHLORIDE IN DEXTROSE	Hospira, Inc.	9679cc05-2f8a-4e88-53b5-6e9122c8b8c0	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018692 application number: NDA018692 ndc (product): 0409-1761

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