NDC 68462-504

Hailey 1.5/30

Norethindrone Acetate And Ethinyl Estradiol

Hailey 1.5/30 is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

Product ID68462-504_8660648a-5595-4f56-b93c-60172827b3cd
NDC68462-504
Product TypeHuman Prescription Drug
Proprietary NameHailey 1.5/30
Generic NameNorethindrone Acetate And Ethinyl Estradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA209297
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength0 mg/1; mg/1
Pharm ClassesEstrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68462-504-81

3 POUCH in 1 CARTON (68462-504-81) > 1 BLISTER PACK in 1 POUCH (68462-504-79) > 21 TABLET in 1 BLISTER PACK
Marketing Start Date2018-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-504-79 [68462050479]

Hailey 1.5/30 TABLET
Marketing CategoryANDA
Application NumberANDA209297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-05

NDC 68462-504-81 [68462050481]

Hailey 1.5/30 TABLET
Marketing CategoryANDA
Application NumberANDA209297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-05

Drug Details

Active Ingredients

IngredientStrength
NORETHINDRONE ACETATE1.5 mg/1

OpenFDA Data

SPL SET ID:021df70a-0c37-4237-a2f7-2597ff6d41f5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359022
  • 1359028
  • 2047760

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estrogen [EPC]
    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estrogen [EPC]

    NDC Crossover Matching brand name "Hailey 1.5/30" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

    NDCBrand NameGeneric Name
    68462-503Hailey 1.5/30Hailey 1.5/30
    68462-504Hailey 1.5/30Hailey 1.5/30
    0093-3122Jintelinorethindrone acetate and ethinyl estradiol
    0555-9025JunelNorethindrone Acetate and Ethinyl Estradiol
    0555-9027JunelNorethindrone Acetate and Ethinyl Estradiol
    51285-127LoestrinNorethindrone Acetate and Ethinyl Estradiol
    51285-131LoestrinNorethindrone Acetate and Ethinyl Estradiol
    51862-007MICROGESTIN 1/20norethindrone acetate and ethinyl estradiol
    0378-7274NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7280NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7283NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    0378-7288NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50090-2478NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50090-3395NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLnorethindrone acetate and ethinyl estradiol
    50102-128TARINA Fe 1/20norethindrone acetate and ethinyl estradiol
    21695-685Tilia FeNorethindrone Acetate and Ethinyl Estradiol
    0555-9032Tri-Legest FeNorethindrone Acetate and Ethinyl Estradiol
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