NDC 0093-3223

Estradiol

Estradiol

Estradiol is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Estradiol.

• Product ID: 0093-3223_298666b0-57a0-464e-b349-a708aa4f63a2
• NDC: 0093-3223
• Product Type: Human Prescription Drug
• Proprietary Name: Estradiol
• Generic Name: Estradiol
• Dosage Form: Insert
• Route of Administration: VAGINAL
• Marketing Start Date: 2017-07-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206388
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: ESTRADIOL
• Active Ingredient Strength: 10 ug/1
• Pharm Classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0093-3223-08

8 BLISTER PACK in 1 CARTON (0093-3223-08) > 1 APPLICATOR in 1 BLISTER PACK > 1 INSERT in 1 APPLICATOR

• Marketing Start Date: 2017-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-3223-19 [00093322319]

Estradiol INSERT

• Marketing Category: ANDA
• Application Number: ANDA206388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-24

NDC 0093-3223-97 [00093322397]

Estradiol INSERT

• Marketing Category: ANDA
• Application Number: ANDA206388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-24

NDC 0093-3223-08 [00093322308]

Estradiol INSERT

• Marketing Category: ANDA
• Application Number: ANDA206388
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-24

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	10 ug/1

OpenFDA Data

• SPL SET ID: 8cb31c7c-fba8-4201-833d-844ea1a8a4de
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • 4TI98Z838E
• RxNorm Concept Unique ID - RxCUI:
  • 884707

Pharmacological Class

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

NDC Crossover Matching brand name "Estradiol" or generic name "Estradiol"

NDC	Brand Name	Generic Name
68071-3326	Estradiol	Estradiol
68071-3170	Estradiol	Estradiol
68071-3202	Estradiol	Estradiol
68071-3394	ESTRADIOL	ESTRADIOL
68071-4485	ESTRADIOL	ESTRADIOL
68071-4195	Estradiol	Estradiol
68788-7054	Estradiol	Estradiol
68788-7102	ESTRADIOL	ESTRADIOL
68788-7332	ESTRADIOL	ESTRADIOL
68788-9416	Estradiol	Estradiol
68968-3410	Estradiol	Estradiol
68968-3450	Estradiol	Estradiol
68788-9901	Estradiol	Estradiol
68968-3475	Estradiol	Estradiol
68968-3425	Estradiol	Estradiol
68968-3437	Estradiol	Estradiol
69238-1630	Estradiol	Estradiol
69238-1631	Estradiol	Estradiol
69238-1629	Estradiol	Estradiol
69238-1632	Estradiol	Estradiol
69238-1633	Estradiol	Estradiol
0555-0886	Estradiol	Estradiol
0555-0887	Estradiol	Estradiol
0555-0899	Estradiol	Estradiol
70518-0920	Estradiol	Estradiol
70518-0834	Estradiol	Estradiol
71335-0226	ESTRADIOL	ESTRADIOL
71335-0430	Estradiol	Estradiol
71335-0201	Estradiol	Estradiol
71335-0797	ESTRADIOL	ESTRADIOL
71335-0445	Estradiol	Estradiol
0781-7144	Estradiol	Estradiol
0781-7129	Estradiol	Estradiol
0781-7156	Estradiol	Estradiol
0781-7138	Estradiol	Estradiol
0781-7167	Estradiol	Estradiol
10544-069	Estradiol	Estradiol
10544-070	Estradiol	Estradiol
0093-3541	Estradiol	Estradiol
0093-3223	Estradiol	Estradiol
21695-613	Estradiol	Estradiol
21695-623	Estradiol	Estradiol
23155-014	Estradiol	Estradiol
23155-013	Estradiol	Estradiol
23155-015	Estradiol	Estradiol
33261-714	Estradiol	Estradiol
33261-667	Estradiol	Estradiol
42806-087	ESTRADIOL	ESTRADIOL
43063-706	Estradiol	Estradiol
42806-089	ESTRADIOL	ESTRADIOL