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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Junel
- Brand name suffix
- 21 Day
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 20 ug/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1358762, 1358776, 1358780 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-172-21 | Junel21 Day | 1 in 1 POUCH | TABLET | 1 | | 1 |
| 82804-172-21 | Junel21 Day | 3 in 1 CARTON | TABLET | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-172 | JUNEL 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20241215_56e91ad4-f31b-494d-9e75-6dd4f396779c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |