LILETTA

Product NDC
0023-5858
11-digit product format
000235858
Labeler code
0023
Product ID
0023-5858_2bd36b89-e6f6-4da1-97c4-3516f2a06b73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel
Dosage form
INTRAUTERINE DEVICE
Route
INTRAUTERINE
Labeler
Allergan, Inc.
Application
NDA206229
Marketing category
NDA
Marketing start
2016-05-31
Substance
LEVONORGESTREL
Active strength
52 mg/1
Pharmacologic classes
Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LILETTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL52 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5W7SIA7YZW
Rxcui1605252, 1605257

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-5858-01LILETTA1 in 1 CARTONINTRAUTERINE DEVICE122
0023-5858-01LILETTA1 in 1 TRAYINTRAUTERINE DEVICE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-5858-01EA - Each0023-585858622d7d-11be-4da0-a835-e0d07a288d5412016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-5858LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ALLERGAN, INC.]22Current NDC, Legacy NDC, 2 package rows20241024_aaf0eb2a-f88a-4f26-a445-0fd30176c326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605252levonorgestrel 52 MG, 8 Year Intrauterine SystemPSNaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605257Liletta 52 MG, 8 Year Intrauterine SystemPSNaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605257levonorgestrel 0.000813 MG/HR Intrauterine System [Liletta]SBDaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605252levonorgestrel 0.000813 MG/HR Intrauterine SystemSCDaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605252levonorgestrel 52 MG, 8 Year Intrauterine SystemSYaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605257Liletta 0.000813 MG/HR Intrauterine SystemSYaaf0eb2a-f88a-4f26-a445-0fd30176c32622
1605257Liletta 52 MG Intrauterine SystemSYaaf0eb2a-f88a-4f26-a445-0fd30176c32622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-5858-01000235858011 TRAY in 1 CARTON (0023-5858-01) / 1 INTRAUTERINE DEVICE in 1 TRAY1 tray2016-05-310000-00-00NoNoCurrent