NDC 0430-0145

femhrt

Norethindrone Acetate/ethinyl Estradiol

femhrt is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Norethindrone Acetate; Ethinyl Estradiol.

• Product ID: 0430-0145_3653e9d8-0a0c-40c9-8fa6-a4dcd6f85ddf
• NDC: 0430-0145
• Product Type: Human Prescription Drug
• Proprietary Name: femhrt
• Generic Name: Norethindrone Acetate/ethinyl Estradiol
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-10-01
• Marketing End Date: 2022-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA021065
• Labeler Name: Allergan, Inc.
• Substance Name: NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
• Active Ingredient Strength: 1 mg/1; ug/1
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0430-0145-14

5 POUCH in 1 CARTON (0430-0145-14) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2009-10-01
• Marketing End Date: 2022-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0430-0145-23 [00430014523]

femhrt TABLET

• Marketing Category: NDA
• Application Number: NDA021065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-10-01
• Marketing End Date: 2013-06-03

NDC 0430-0145-14 [00430014514]

femhrt TABLET

• Marketing Category: NDA
• Application Number: NDA021065
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-10-01

NDC 0430-0145-95 [00430014595]

femhrt TABLET

• Marketing Category: NDA
• Application Number: NDA021065
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-10-01
• Marketing End Date: 2014-02-19

Drug Details

Active Ingredients

Ingredient	Strength
NORETHINDRONE ACETATE	.5 mg/1

OpenFDA Data

• SPL SET ID: 0fece0aa-2b9c-40a3-975e-1ef2c2ef72f2
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 9S44LIC7OJ
  • 423D2T571U
• RxNorm Concept Unique ID - RxCUI:
  • 1251323
  • 1251334
  • 1251335

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 "femhrt" or generic name "Norethindrone Acetate/ethinyl Estradiol"

NDC	Brand Name	Generic Name
0430-0145	femhrt	norethindrone acetate/ethinyl estradiol
16714-407	Larin 1.5/30	Norethindrone Acetate/Ethinyl Estradiol
16714-408	Larin 1/20	Norethindrone Acetate/Ethinyl Estradiol
51862-872	Microgestin 1.5/30	Norethindrone Acetate/Ethinyl Estradiol
51862-868	Microgestin 1/20	Norethindrone Acetate/Ethinyl Estradiol