FDA.reportPublic FDA data

PostDay One-Step

Product NDC
69953-617
11-digit product format
699530617
Labeler code
69953
Product ID
69953-617_0aab0d9b-3db7-7c71-e063-6394a90a9c89
Type
HUMAN OTC DRUG
Nonproprietary name
Levonorgestrel
Dosage form
TABLET
Route
ORAL
Labeler
Rapha Pharmaceuticals, Inc.
Application
ANDA205329
Marketing category
ANDA
Marketing start
2023-01-16
Substance
LEVONORGESTREL
Active strength
1.5 mg/1.5mg
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
PostDay One-Step
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL1.5 mg/1.5mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5W7SIA7YZW
Rxcui483325, 2049247

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69953-617-42PostDay One-Step1 mg in 1 BLISTER PACKTABLET13
69953-617-42PostDay One-Step1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69953-617POSTDAY ONE-STEP (LEVONORGESTREL) TABLET [RAPHA PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20231122_6f7f5697-acb6-ea95-e053-2991aa0ae7c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN6f7f5697-acb6-ea95-e053-2991aa0ae7c73
2049247PostDay One-Step Emergency Contraceptive 1.5 MG Oral TabletPSN6f7f5697-acb6-ea95-e053-2991aa0ae7c73
2049247levonorgestrel 1.5 MG Oral Tablet [PostDay One-Step]SBD6f7f5697-acb6-ea95-e053-2991aa0ae7c73
483325levonorgestrel 1.5 MG Oral TabletSCD6f7f5697-acb6-ea95-e053-2991aa0ae7c73
2049247PostDay One-Step 1.5 MG Oral TabletSY6f7f5697-acb6-ea95-e053-2991aa0ae7c73
2049247PostDay One-Step Emergency Contraceptive 1.5 MG Oral TabletSY6f7f5697-acb6-ea95-e053-2991aa0ae7c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69953-617-42699530617421 BLISTER PACK in 1 CARTON (69953-617-42) / 1 mg in 1 BLISTER PACK1 blister pack2023-01-16NoNoCurrent