Junel
- Product NDC
- 82804-172
- 11-digit product format
- 828040172
- Labeler code
- 82804
- Product ID
- 82804-172_56e91ad4-f31b-494d-9e75-6dd4f396779c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076380
- Marketing category
- ANDA
- Marketing start
- 2003-09-18
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 20; 1 ug/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 423D2T571U | ETHINYL ESTRADIOL | 57-63-6 | ETHINYL ESTRADIOL |
| 9S44LIC7OJ | NORETHINDRONE ACETATE | 51-98-9 | NORETHINDRONE ACETATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-172-21 | 82804017221 | 3 POUCH in 1 CARTON (82804-172-21) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2024-12-06 | No | No | Historical |