Lidocaine and Prilocaine

Product NDC
0115-1468
11-digit product format
001151468
Labeler code
0115
Product ID
0115-1468_ef0e52f0-eafb-4ccc-86f4-19672a142b3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076320
Marketing category
ANDA
Marketing start
2003-08-27
Marketing end
0000-00-00
Substance
LIDOCAINE; PRILOCAINE
Active strength
25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1468-45GM - Gram0115-1468616e3ae1-bfc3-40ca-813c-25f978e7df5912013-02-13
0115-1468-53GM - Gram0115-1468da587c08-1370-4dad-b027-f658d5a23a7212015-05-05
0115-1468-60GM - Gram0115-14686a82e2c3-f9fc-4756-b2f3-12ddb220108a12013-02-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN004da013-8bd9-497a-b38e-14ff86859be75
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD004da013-8bd9-497a-b38e-14ff86859be75
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY004da013-8bd9-497a-b38e-14ff86859be75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1468-45001151468451 TUBE in 1 CARTON (0115-1468-45) > 30 g in 1 TUBE1 tube2003-08-270000-00-00NoNoCurrent
0115-1468-53001151468531 TUBE in 1 CARTON (0115-1468-53) > 5 g in 1 TUBE1 tube2003-08-270000-00-00NoNoCurrent
0115-1468-60001151468605 TUBE in 1 CARTON (0115-1468-60) > 5 g in 1 TUBE5 tube2003-08-270000-00-00NoNoCurrent