Home NDC 84549-209 Chloroprocaine Hydrochloride
Product NDC 84549-209
11-digit product format 845490209
Labeler code 84549
Product ID 84549-209_463ee055-62a2-9709-e063-6294a90aa7ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chloroprocaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler ProPharma Distribution
Application ANDA040273
Marketing category ANDA
Marketing start 1998-11-01
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040273-001 CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 A040273-002 CHLOROPROCAINE HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040273-001 CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 1998-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040273-002 CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE / INJECTION AP 1998-09-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Chloroprocaine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LT7Z1YW11H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1794184 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84549-209-10 Chloroprocaine Hydrochloride 20 mL in 1 VIAL INJECTION, SOLUTION 20 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84549-209-10 84549020910 20 mL in 1 VIAL (84549-209-10) 20 ml 2025-10-10 No No Current