Nesacaine
- Product NDC
- 52584-475
- Requested package NDC
- 52584-475-37
- 11-digit product format
- 525840475
- Labeler code
- 52584
- Product ID
- 52584-475_a6c9dfd2-eede-4b96-b231-392059befa92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chloroprocaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INFILTRATION; PERINEURAL
- Labeler
- General Injectables & Vaccines, Inc
- Application
- NDA009435
- Marketing category
- NDA
- Marketing start
- 2011-10-03
- Marketing end
- 2023-08-31
- Substance
- CHLOROPROCAINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 52584-475 | 52584-475-37 | D | Discontinued by firm | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N009435-001 | NESACAINE | CHLOROPROCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N009435-002 | NESACAINE | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | |
| N009435-003 | NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N009435-004 | NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE / INJECTION | Approved before 1982 | ||
| N009435-006 | NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 |
| N009435-007 | NESACAINE-MPF | CHLOROPROCAINE HYDROCHLORIDE | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N009435-002 | AP |
| N009435-006 | AP |
| N009435-007 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-006 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-007 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | AP | RLD, RS | 1996-05-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-001 | NESACAINE | 1% | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-002 | NESACAINE | 2% | INJECTABLE / INJECTION | AP | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-003 | NESACAINE-MPF | 2% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-004 | NESACAINE-MPF | 3% | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N009435-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N009435-006 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N009435-007 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N009435-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N009435-006 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N009435-007 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N009435-007 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009435-007 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-006 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N009435-007 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-006 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009435-007 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-006 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009435-007 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009435-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009435-006 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009435-007 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009435-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009435-006 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009435-007 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009435-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009435-006 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009435-007 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009435-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009435-006 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009435-007 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N009435-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N009435-006 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N009435-007 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009435-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009435-006 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009435-007 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009435-002 | AP | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Chloroprocaine Hydrochloride | ACTIVE INGREDIENT | LT7Z1YW11H | NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
| Chloroprocaine | ACTIVE MOIETY | 5YVB0POT2H | NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| (CHLOROPROCAINE HCI | (CHLOROPROCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 94d13f48-fbca-67b4-e053-2995a90a791b | 2024-01-29 | Warnings, Adverse reactions | 009435 NDA009435 |
| CHLOROPROCAINE HCI | CHLOROPROCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 9611d194-b6dd-93f4-e053-2a95a90a1816 | 2024-01-28 | Warnings, Adverse reactions | 009435 NDA009435 |
| CHLOROPROCAINE HCI | CHLOROPROCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 94d13f48-fbc6-67b4-e053-2995a90a791b | 2024-01-22 | Warnings, Adverse reactions | 009435 NDA009435 |
| Nesacaine | CHLOROPROCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | a844e68a-1462-40e4-be5e-f56214906eb9 | 2022-09-01 | Warnings, Adverse reactions | 009435 NDA009435 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52584-475-37 | 52584047537 | 1 VIAL in 1 BAG (52584-475-37) > 30 mL in 1 VIAL | 1 vial | 2011-10-03 | 2023-08-31 | No | No | Current |