NDC 51285-131

Loestrin 21 Day

Norethindrone Acetate And Ethinyl Estradiol

Loestrin 21 Day is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Women's Health, Inc.. The primary component is Ethinyl Estradiol; Norethindrone Acetate.

• Product ID: 51285-131_636a253c-cc1c-4e19-99c8-a9cca597a891
• NDC: 51285-131
• Product Type: Human Prescription Drug
• Proprietary Name: Loestrin 21 Day
• Generic Name: Norethindrone Acetate And Ethinyl Estradiol
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-02-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076380
• Labeler Name: Teva Women's Health, Inc.
• Substance Name: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
• Active Ingredient Strength: 20 ug/1; mg/1
• Pharm Classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 51285-131-97

5 POUCH in 1 CARTON (51285-131-97) > 1 BLISTER PACK in 1 POUCH > 21 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2015-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51285-131-97 [51285013197]

Loestrin 21 Day TABLET

• Marketing Category: ANDA
• Application Number: ANDA076380
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-02-26

Drug Details

Active Ingredients

Ingredient	Strength
NORETHINDRONE ACETATE	1 mg/1

OpenFDA Data

• SPL SET ID: f29ebcb5-7e65-4092-bfaa-f5ec026fc255
• Manufacturer:
  • Teva Women's Health, Inc.
• UNII:
  • 9S44LIC7OJ
  • 423D2T571U
• RxNorm Concept Unique ID - RxCUI:
  • 1358776
  • 1359028
  • 1358763
  • 1358762
  • 1359023
  • 259176
  • 1358781
  • 1359026
  • 1359022
  • 1358770
  • 1359031

Pharmacological Class

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

NDC Crossover Matching brand name "Loestrin 21 Day" or generic name "Norethindrone Acetate And Ethinyl Estradiol"

NDC	Brand Name	Generic Name
0093-3122	Jinteli	norethindrone acetate and ethinyl estradiol
0555-9025	Junel	Norethindrone Acetate and Ethinyl Estradiol
0555-9027	Junel	Norethindrone Acetate and Ethinyl Estradiol
51285-127	Loestrin	Norethindrone Acetate and Ethinyl Estradiol
51285-131	Loestrin	Norethindrone Acetate and Ethinyl Estradiol
51862-007	MICROGESTIN 1/20	norethindrone acetate and ethinyl estradiol
0378-7274	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
0378-7280	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
0378-7283	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
0378-7288	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
50090-2478	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
50090-3395	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	norethindrone acetate and ethinyl estradiol
50102-128	TARINA Fe 1/20	norethindrone acetate and ethinyl estradiol
21695-685	Tilia Fe	Norethindrone Acetate and Ethinyl Estradiol
0555-9032	Tri-Legest Fe	Norethindrone Acetate and Ethinyl Estradiol