0378-7295 : Estradiol and Norethindrone Acetate Oral Tablet


NDC: 0378-7295
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Estradiol and Norethindrone Acetate
Dosage Form: Oral Tablet
Application #: ANDA207261
Rev. Date: 


Appearance:


Markings: 263
Shapes:  Round
Colors:  Orange
Size (mm): 6
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0378-7295-53: 3 POUCH IN 1 CARTON (0378‑7295‑53) > 1 BLISTER PACK IN 1 POUCH (0378‑7295‑85) > 28 TABLET IN 1 BLISTER PACK

Active Ingredients:

  • Estradiol
  • Norethindrone Acetate

Dosage Strength:

  • 1 mg
  • .5 mg

Inactive Ingredients:

  • Copovidone
  • Fd&c Yellow No. 6
  • Lactose Monohydrate
  • Magnesium Stearate
  • Starch, Corn
  • Talc /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-7294 Estradiol and Norethindrone Acetate Oral Tablet by Mylan Pharmaceuticals Inc.
  • 50742-657 Estradiol and Norethindrone Acetate Oral Tablet by Ingenus Pharmaceuticals, LLC
  • 50742-658 Estradiol and Norethindrone Acetate Oral Tablet by Ingenus Pharmaceuticals, LLC
  • 79929-012 Estradiol and Norethindrone Acetate Oral Tablet by Naari Pte. Limited

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.