PIMTREA
- Product NDC
- 16714-404
- 11-digit product format
- 167140404
- Labeler code
- 16714
- Product ID
- 16714-404_12f60f95-d164-4964-bf6a-dc3cfb42bac0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desogestrel/ethinyl estradiol and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Northstar Rx LLC
- Application
- ANDA091247
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PIMTREA
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 248310, 249357, 748797, 759743, 1438778 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-404-01 | PIMTREA | 1 in 1 PACKET | KIT | 1 | 8 | |
| 16714-404-01 | PIMTREA | 1 in 1 BLISTER PACK | KIT | 1 | 8 | |
| 16714-404-02 | PIMTREA | 1 in 1 BLISTER PACK | KIT | 1 | 8 | |
| 16714-404-02 | PIMTREA | 1 in 1 CARTON | KIT | 1 | 8 | |
| 16714-404-03 | PIMTREA | 3 in 1 CARTON | KIT | 3 | 8 | |
| 16714-404-03 | PIMTREA | 1 in 1 BLISTER PACK | KIT | 1 | 8 | |
| 16714-404-04 | PIMTREA | 6 in 1 CARTON | KIT | 6 | 8 | |
| 16714-404-04 | PIMTREA | 1 in 1 BLISTER PACK | KIT | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-404-01 | EA - Each | 16714-404 | e0f6a06b-aedd-41fa-b97d-5d9f1a2053d5 | 1 | 2014-01-04 |
| 16714-404-04 | EA - Each | 16714-404 | 8910b23b-50cc-4d06-ba01-85783777decf | 1 | 2013-12-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1438778 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Pimtrea Pack] | BPCK | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 759743 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 759743 | Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day Pack | PSN | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 748797 | inert 1 MG Oral Tablet | PSN | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 1438778 | Pimtrea 28 Day Pack | PSN | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
| 1438778 | Pimtrea 28 Day Pack | SY | b716fd2a-b186-447a-85bd-6302284d14e5 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-404-01 | 16714040401 | 1 BLISTER PACK in 1 PACKET (16714-404-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2013-09-13 | 0000-00-00 | No | No | Current |
| 16714-404-02 | 16714040402 | 1 BLISTER PACK in 1 CARTON (16714-404-02) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2013-09-13 | 0000-00-00 | No | No | Current |
| 16714-404-03 | 16714040403 | 3 BLISTER PACK in 1 CARTON (16714-404-03) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2013-09-13 | 0000-00-00 | No | No | Current |
| 16714-404-04 | 16714040404 | 6 BLISTER PACK in 1 CARTON (16714-404-04) / 1 KIT in 1 BLISTER PACK | 6 blister pack | 2013-09-13 | 0000-00-00 | No | No | Current |