CHLOROPROCAINE HCI

Product NDC
51662-1408
11-digit product format
516621408
Labeler code
51662
Product ID
51662-1408_0ffba8c5-bf5c-a665-e063-6294a90a64f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROPROCAINE HCI
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA009435
Marketing category
NDA
Marketing start
2019-10-29
Substance
CHLOROPROCAINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N009435-001NESACAINECHLOROPROCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONRLD, Approved before 1982
N009435-002NESACAINECHLOROPROCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, Approved before 1982
N009435-003NESACAINE-MPFCHLOROPROCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982
N009435-004NESACAINE-MPFCHLOROPROCAINE HYDROCHLORIDE3%INJECTABLE / INJECTIONApproved before 1982
N009435-006NESACAINE-MPFCHLOROPROCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAPRLD, RS1996-05-02
N009435-007NESACAINE-MPFCHLOROPROCAINE HYDROCHLORIDE3%INJECTABLE / INJECTIONAPRLD, RS1996-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N009435-002AP
N009435-006AP
N009435-007AP

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-02caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-006NESACAINE-MPF2%INJECTABLE / INJECTIONAPRLD, RS1996-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-007NESACAINE-MPF3%INJECTABLE / INJECTIONAPRLD, RS1996-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-001NESACAINE1%INJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-002NESACAINE2%INJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-003NESACAINE-MPF2%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-004NESACAINE-MPF3%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N009435-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N009435-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N009435-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009435-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009435-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N009435-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009435-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009435-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-006AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009435-007AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-006AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009435-007AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009435-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009435-006AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009435-007AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009435-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009435-006AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009435-007AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009435-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009435-006AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009435-007AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009435-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N009435-006AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N009435-007AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009435-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009435-006AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009435-007AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009435-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009435-006AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009435-007AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009435-002AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
CHLOROPROCAINE HCI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LT7Z1YW11HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1794184Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9611d194-b6dd-93f4-e053-2a95a90a1816Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5d35ea28-18de-4c43-8b81-d4140e17b91aProduct name120230912
9f0ed4af-e581-4924-816e-213668654c3dProduct name120171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1408-1CHLOROPROCAINE HCI20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
51662-1408-2CHLOROPROCAINE HCI1 in 1 POUCHINJECTION, SOLUTION15
51662-1408-2CHLOROPROCAINE HCI20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
51662-1408-3CHLOROPROCAINE HCI25 in 1 CASEINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1408CHLOROPROCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 4 package rows20240129_9611d194-b6dd-93f4-e053-2a95a90a1816.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
(CHLOROPROCAINE HCI(CHLOROPROCAINE HCIHF Acquisition Co LLC, DBA HealthFirst94d13f48-fbca-67b4-e053-2995a90a791b2024-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 009435
application number: NDA009435
CHLOROPROCAINE HCICHLOROPROCAINE HCIHF Acquisition Co LLC, DBA HealthFirst9611d194-b6dd-93f4-e053-2a95a90a18162024-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 009435
application number: NDA009435
ndc (product): 51662-1408
CHLOROPROCAINE HCICHLOROPROCAINE HCIHF Acquisition Co LLC, DBA HealthFirst94d13f48-fbc6-67b4-e053-2995a90a791b2024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 009435
application number: NDA009435
NesacaineCHLOROPROCAINE HYDROCHLORIDEFresenius Kabi USA, LLCa844e68a-1462-40e4-be5e-f56214906eb92022-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 009435
application number: NDA009435

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794184chloroprocaine HCl 2 % in 20 ML InjectionPSN9611d194-b6dd-93f4-e053-2a95a90a18165
179418420 ML chloroprocaine hydrochloride 20 MG/ML InjectionSCD9611d194-b6dd-93f4-e053-2a95a90a18165
1794184chloroprocaine hydrochloride 2 % per 20 ML InjectionSY9611d194-b6dd-93f4-e053-2a95a90a18165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1408-15166214080120 mL in 1 VIAL, SINGLE-DOSE (51662-1408-1) 20 ml2019-10-290000-00-00NoNoCurrent
51662-1408-2516621408021 in 1 POUCHHistorical
51662-1408-35166214080325 POUCH in 1 CASE (51662-1408-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1408-2) / 20 mL in 1 VIAL, SINGLE-DOSE25 pouch2023-01-080000-00-00NoNoCurrent