Lidocaine Hydrochloride
- Product NDC
- 0143-9594
- 11-digit product format
- 001439594
- Labeler code
- 0143
- Product ID
- 0143-9594_a7da0a25-5efb-48fa-9063-f7c0423f820f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; INTRACAUDAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA084625
- Marketing category
- ANDA
- Marketing start
- 1975-06-16
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 20 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidocaine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V13007Z41A |
| Rxcui | 1737566, 1737761 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9594-01 | Lidocaine Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 8 | |
| 0143-9594-25 | Lidocaine Hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9594-01 | ML - Milliliter | 0143-9594 | 2ae2f939-c1f1-483a-a650-caa59cb89c4e | 1 | 2017-08-11 |
| 0143-9594-25 | ML - Milliliter | 0143-9594 | 03908100-8616-4059-bfcf-d5f6141d9982 | 1 | 2017-08-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0143-9594 | LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240828_1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1737566 | lidocaine HCl 1 % in 5 ML Injection | PSN | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737566 | 5 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737566 | lidocaine HCl 1 % per 5 ML Injection | SY | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737761 | lidocaine HCl 100 MG per 5 ML Injection | SY | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737761 | lidocaine HCl 2 % per 5 ML Injection | SY | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737566 | lidocaine HCl 50 MG per 5 ML Injection | SY | 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 | 8 |
| 1737566 | lidocaine HCl 1 % in 5 ML Injection | PSN | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737566 | 5 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737566 | lidocaine HCl 1 % per 5 ML Injection | SY | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737761 | lidocaine HCl 100 MG per 5 ML Injection | SY | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737761 | lidocaine HCl 2 % per 5 ML Injection | SY | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737566 | lidocaine HCl 50 MG per 5 ML Injection | SY | 995e68a7-6986-423e-e053-2995a90acd98 | 6 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | 89691444-7bfb-3314-e053-2a95a90a268e | 2 |
| 1737761 | lidocaine HCl 2 % in 5 ML Injection | PSN | fecd1797-7757-4da8-b3a1-24b258634243 | 2 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | 89691444-7bfb-3314-e053-2a95a90a268e | 2 |
| 1737761 | 5 ML lidocaine hydrochloride 20 MG/ML Injection | SCD | fecd1797-7757-4da8-b3a1-24b258634243 | 2 |
| 1737761 | lidocaine HCl 100 MG per 5 ML Injection | SY | 89691444-7bfb-3314-e053-2a95a90a268e | 2 |
| 1737761 | lidocaine HCl 100 MG per 5 ML Injection | SY | fecd1797-7757-4da8-b3a1-24b258634243 | 2 |
| 1737761 | lidocaine HCl 2 % per 5 ML Injection | SY | 89691444-7bfb-3314-e053-2a95a90a268e | 2 |
| 1737761 | lidocaine HCl 2 % per 5 ML Injection | SY | fecd1797-7757-4da8-b3a1-24b258634243 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0143-9594-01 | 00143959401 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | Historical | ||||
| 0143-9594-25 | 00143959425 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9594-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9594-01) | 1975-06-16 | 0000-00-00 | No | No | Current |