Junel
- Product NDC
- 68788-8113
- 11-digit product format
- 687888113
- Labeler code
- 68788
- Product ID
- 68788-8113_38fda622-06ad-497b-80ab-ba312ee919f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
- Dosage form
- KIT
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA076064
- Marketing category
- ANDA
- Marketing start
- 2021-12-06
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-8113-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-c96e-0266-e053-dadaa90a7c1a | Junel ® 21 Day (norethindrone acetate and ethinyl estradiol tablets USP) Junel ® Fe 28 Day (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8113-2 | JunelFe 28 Day | 1 in 1 POUCH | KIT | 1 | 1 | |
| 68788-8113-2 | JunelFe 28 Day | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8113-2 | EA - Each | 68788-8113 | 5a176e36-4901-4b83-b3e8-67b37941d5e5 | 1 | 2022-01-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8113 | JUNEL FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [PREFERRED PHARMACEUTICALS INC.] | 1 | Legacy NDC, 2 package rows | 20211208_38fda622-06ad-497b-80ab-ba312ee919f4.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359025 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Junel Fe 1.5/30 28 Day] | BPCK | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359023 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359023 | Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359025 | Junel Fe 1.5/30 28 Day Pack | PSN | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359022 | norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet | PSN | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359022 | ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet | SCD | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359022 | ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet | SY | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359025 | Junel Fe 1.5/30 28 Day Pack | SY | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
| 1359025 | Junel Fe 28 Day Pack | SY | 38fda622-06ad-497b-80ab-ba312ee919f4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-8113-2 | 68788811302 | 1 BLISTER PACK in 1 POUCH (68788-8113-2) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2021-12-06 | 0000-00-00 | No | No | Current |