LIDOCAINE HYDROCHLORIDE
- Product NDC
- 0781-3537
- Requested package NDC
- 0781-3537-96
- 11-digit product format
- 007813537
- Labeler code
- 0781
- Product ID
- 0781-3537_5d258dce-741a-64e2-e063-6294a90a49bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
- Labeler
- Sandoz Inc.
- Application
- ANDA219535
- Marketing category
- ANDA
- Marketing start
- 2026-10-12
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219535-001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | |
| A219535-002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219535-001 | AP |
| A219535-002 | 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 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A219535-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A219535-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A219535-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219535-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219535-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219535-001 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-002 | AP | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LIDOCAINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 10 mg/mL |
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 |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Anthea Pharma Private Limited | 240c4744-e58c-4c08-93ad-8d6418c4f8a9 | 2026-02-11 | Warnings, Adverse reactions | 219535 ANDA219535 |
| lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Avenacy, LLC | 46480253-29b9-4d7f-98ed-10377929026b | 2026-01-13 | Warnings, Adverse reactions | 219535 ANDA219535 |
| lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 4643042c-ec95-3bad-e063-6294a90a8250 | 2025-12-18 | Warnings, Adverse reactions | 219535 ANDA219535 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-3537-96 | 00781353796 | 25 VIAL in 1 CARTON (0781-3537-96) / 2 mL in 1 VIAL (0781-3537-72) | 25 vial | 2026-10-12 | No | No | Current |