NDC 16571-658

Norethindrone acetate

Norethindrone Acetate

Norethindrone acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Norethindrone Acetate.

• Product ID: 16571-658_6c48c0f2-586b-48df-bb15-bff658a3b650
• NDC: 16571-658
• Product Type: Human Prescription Drug
• Proprietary Name: Norethindrone acetate
• Generic Name: Norethindrone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206490
• Labeler Name: Rising Pharmaceuticals, Inc.
• Substance Name: NORETHINDRONE ACETATE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 16571-658-05

50 TABLET in 1 BOTTLE (16571-658-05)

• Marketing Start Date: 2018-11-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16571-658-05 [16571065805]

Norethindrone acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA206490
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-05

NDC 16571-658-50 [16571065850]

Norethindrone acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA206490
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-05

Drug Details

Active Ingredients

Ingredient	Strength
NORETHINDRONE ACETATE	5 mg/1

OpenFDA Data

• SPL SET ID: 6c48c0f2-586b-48df-bb15-bff658a3b650
• Manufacturer:
  • Rising Pharmaceuticals, Inc.
• UNII:
  • 9S44LIC7OJ
• RxNorm Concept Unique ID - RxCUI:
  • 1000405
• UPC Code:
  • 0316571658053
  • 0316571658503

Pharmacological Class

• Progesterone Congeners [CS]
• Progestin [EPC]
• Progesterone Congeners [CS]
• Progestin [EPC]

NDC Crossover Matching brand name "Norethindrone acetate" or generic name "Norethindrone Acetate"

NDC	Brand Name	Generic Name
0179-0227	Norethindrone Acetate	Norethindrone Acetate
0378-7291	Norethindrone Acetate	Norethindrone Acetate
0555-0211	Norethindrone Acetate	Norethindrone Acetate
16571-658	Norethindrone acetate	norethindrone acetate
42291-650	Norethindrone Acetate	Norethindrone
50268-602	Norethindrone Acetate	Norethindrone
50742-267	Norethindrone acetate	norethindrone acetate
65162-475	Norethindrone Acetate	Norethindrone
65862-715	Norethindrone acetate	Norethindrone acetate
68462-304	Norethindrone Acetate	Norethindrone Acetate
51285-424	Aygestin	Norethindrone Acetate