Prescription drug · ANDA
glydo (lidocaine hydrochloride) NDC 25021-673
Lidocaine hydrochloride anhydrous 20 mg/mL · Jelly · Topical · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-673-76 | 25021067376 | 10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGEMarketed from Sep 15, 2014 | |
| 25021-673-77 | 25021067377 | 10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGEMarketed from Sep 15, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- glydo
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride anhydrous — 20 mg/mL
- Dosage form
- Jelly
- Route
- Topical
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201094
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 25021-673_17e6ad03-b5bc-4930-8db5-e787ef954448SPL ID 17e6ad03-b5bc-4930-8db5-e787ef954448SPL set ID 65760723-75cd-472c-96e1-7d05f95b4686RxCUI 1011852, 1549447UNII EC2CNF7XFP
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N425021067376followed by a unit qualifier and the quantityPackage 25021-0673-76. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
GLYDO (lidocaine HCl jelly) 2% is an amide local anesthetic indicated: for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis as an anesthetic lubricant for oral and nasal endotracheal intubation GLYDO (lidocaine HCl jelly) 2% contains lidocaine, an amide local anesthetic, and is indicated in adult patients: for prevention and control of pain in procedures involving the male and female urethra ( 1 ) for topical treatment of painful urethritis ( 1 ) as an anesthetic lubricant for oral and nasal endotracheal intubation ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201094
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| GLYDO- lidocaine hydrochloride jelly | Lidocaine hydrochloride anhydrous 20 mg/mL | JellyTopical | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1652 |