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

openFDA Listing Details

Product ID: 69953-617_0aab0d9b-3db7-7c71-e063-6394a90a9c89
SPL ID: 0aab0d9b-3db7-7c71-e063-6394a90a9c89
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: PostDay One-Step
Generic name: Levonorgestrel
Dosage form: TABLET
Route: ORAL
Marketing start: 2023-01-16
Marketing category: ANDA
Application number: ANDA205329
Pharmacologic classes: Inhibit Ovum Fertilization [PE]; Progesterone Congeners [CS]; Progestin [EPC]; Progestin-containing Intrauterine System [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
LEVONORGESTREL	1.5 mg/1.5mg

Package NDC	Description	Marketing start	Sample
69953-617-42	1 BLISTER PACK in 1 CARTON (69953-617-42) / 1 mg in 1 BLISTER PACK	2023-01-16	No

UNII	Preferred term	Registry number	Matched term
5W7SIA7YZW	LEVONORGESTREL	797-63-7	LEVONORGESTREL

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69953-617-42	69953061742	1 BLISTER PACK in 1 CARTON (69953-617-42) / 1 mg in 1 BLISTER PACK	1 blister pack	2023-01-16	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
PostDay One-Step - Rapha Pharmaceuticals, Inc.	Rapha Pharmaceuticals, Inc.	2023-11-21	HUMAN OTC DRUG LABEL	3