Levonorgestrel

Product NDC
63704-009
11-digit product format
637040009
Labeler code
63704
Product ID
63704-009_f9c3c141-3ac1-4e8c-ac2d-e57fac0be7a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacist Pharmaceutical, LLC
Application
ANDA202508
Marketing category
ANDA
Marketing start
2013-06-11
Marketing end
0000-00-00
Substance
LEVONORGESTREL
Active strength
2 mg/1
Pharmacologic classes
Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63704-009-01Levonorgestrel1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63704-009-01EA - Each63704-009735306b8-0c55-4874-b6f1-cc4ca7bb635112013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63704-009LEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]1Legacy NDC, 1 package rows20130729_8abfde83-0ee3-4642-89cf-1d5ff423da31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN8abfde83-0ee3-4642-89cf-1d5ff423da311
483325levonorgestrel 1.5 MG Oral TabletSCD8abfde83-0ee3-4642-89cf-1d5ff423da311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63704-009-01637040009011 in 1 CARTONHistorical