Search by Drug Name or NDC
NDC 68180-0853-13 Fallback Solo 1.5 mg/1 Details
Fallback Solo 1.5 mg/1
Fallback Solo is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is LEVONORGESTREL.
MedlinePlus Drug Summary
Levonorgestrel is used to prevent pregnancy after unprotected sexual intercourse (sex without any method of birth control or with a birth control method that failed or was not used properly [e.g., a condom that slipped or broke or birth control pills that were not taken as scheduled]). Levonorgestrel should not be used to prevent pregnancy on a regular basis. This medication is to be used as an emergency contraceptive or backup in case regular birth control fails or is used incorrectly. Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy. Levonorgestrel may prevent pregnancy, but it will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 68180-0853-13Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levonorgestrel
Product Information
| NDC | 68180-0853 |
|---|---|
| Product ID | 68180-853_db552971-b650-4a8f-94ac-2bee05b8ad70 |
| Associated GPIs | |
| GCN Sequence Number | 058193 |
| GCN Sequence Number Description | levonorgestrel TABLET 1.5 MG ORAL |
| HIC3 | G8A |
| HIC3 Description | CONTRACEPTIVES,ORAL |
| GCN | 23549 |
| HICL Sequence Number | 007318 |
| HICL Sequence Number Description | LEVONORGESTREL |
| Brand/Generic | Generic |
| Proprietary Name | Fallback Solo |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levonorgestrel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 1.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVONORGESTREL |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Pharmaceutical Class | Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201446 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 68180-0853-13 (68180085313)
| NDC Package Code | 68180-853-13 |
|---|---|
| Billing NDC | 68180085313 |
| Package | 1 BLISTER PACK in 1 CARTON (68180-853-13) / 1 TABLET in 1 BLISTER PACK (68180-853-11) |
| Marketing Start Date | 2014-07-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |