Lignospan Standard
- Product NDC
- 0362-1095
- 11-digit product format
- 003621095
- Labeler code
- 0362
- Product ID
- 0362-1095_5dd0f0a3-adbd-4a2f-90f7-a998735ef69a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lidocaine Hydrochloride and Epinephrine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Septodont, Inc.
- Application
- ANDA088390
- Marketing category
- ANDA
- Marketing start
- 2017-11-28
- Substance
- EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
- Active strength
- .01; 20 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lignospan Standard
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINEPHRINE BITARTRATE | .01 mg/mL |
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 30Q7KI53AK, V13007Z41A |
| Rxcui | 1011809, 1293648 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0362-1095-60 | Lignospan Standard | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 8 |
| 0362-1095-60 | Lignospan Standard | 10 in 1 BLISTER PACK | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0362-1095 | LIGNOSPAN STANDARD (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240209_f902d2b4-28fc-41b1-a9f7-0d1a63c598aa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0362-1095-60 | 00362109560 | 5 BLISTER PACK in 1 CARTON (0362-1095-60) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE | 5 blister pack | 2017-11-28 | 0000-00-00 | No | No | Current |