FDA.reportPublic FDA data

glydo

Product NDC
25021-673
11-digit product format
250210673
Labeler code
25021
Product ID
25021-673_17e6ad03-b5bc-4930-8db5-e787ef954448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
JELLY
Route
TOPICAL
Labeler
Sagent Pharmaceuticals
Application
ANDA201094
Marketing category
ANDA
Marketing start
2014-09-15
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
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
glydo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1011852, 1549447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-673-76glydo10 in 1 CARTONJELLY1012
25021-673-76glydo6 mL in 1 SYRINGEJELLY612
25021-673-77glydo10 in 1 CARTONJELLY1012
25021-673-77glydo11 mL in 1 SYRINGEJELLY1112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-673-76ML - Milliliter25021-673c9e0a7c8-aea7-46cb-b098-fc9c572577ba12015-01-05
25021-673-77ML - Milliliter25021-6736015f4b7-ef41-40f5-a7ff-b413eafa596e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lidocaine hydrochloride anhydrousACTIVE INGREDIENTEC2CNF7XFPGLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS]7
lidocaineACTIVE MOIETY98PI200987GLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOGLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS]7
sodium hydroxideINACTIVE INGREDIENT55X04QC32IGLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-673GLYDO (LIDOCAINE HYDROCHLORIDE) JELLY [SAGENT PHARMACEUTICALS]11Current NDC, Legacy NDC, 4 package rows20220728_65760723-75cd-472c-96e1-7d05f95b4686.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549447Glydo 2 % Topical JellyPSN65760723-75cd-472c-96e1-7d05f95b468612
1011852lidocaine HCl 2 % Topical GelPSN65760723-75cd-472c-96e1-7d05f95b468612
1549447lidocaine hydrochloride 0.02 MG/MG Topical Gel [Glydo]SBD65760723-75cd-472c-96e1-7d05f95b468612
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD65760723-75cd-472c-96e1-7d05f95b468612
1549447Glydo 2 % Topical GelSY65760723-75cd-472c-96e1-7d05f95b468612
1011852lidocaine hydrochloride 2 % Topical JellySY65760723-75cd-472c-96e1-7d05f95b468612
1011852lidocaine HCl 2 % Topical GelPSN3364b25d-bf30-c028-e063-6394a90a80081
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD3364b25d-bf30-c028-e063-6394a90a80081
1011852lidocaine hydrochloride 2 % Topical JellySY3364b25d-bf30-c028-e063-6394a90a80081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-673-762502106737610 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE10 syringe2014-09-150000-00-00NoNoCurrent
25021-673-772502106737710 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE10 syringe2014-09-150000-00-00NoNoCurrent