PIRMELLA 7/7/7
- Product NDC
- 68180-892
- 11-digit product format
- 681800892
- Labeler code
- 68180
- Product ID
- 68180-892_74611754-4ad2-4f50-a93e-7f001a84fe89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NORETHINDRONE AND ETHINYL ESTRADIOL
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA201510
- Marketing category
- ANDA
- Marketing start
- 2019-08-16
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-892-11 | EA - Each | 68180-892 | f8918832-e757-4e99-ad60-09b424f30210 | 1 | 2013-07-02 |
| 68180-892-13 | EA - Each | 68180-892 | 73b137fd-ca9c-424d-95ce-8d943fa06aea | 1 | 2013-07-02 |
| 68180-892-71 | EA - Each | 68180-892 | dd770b07-34e5-4ea9-9aa9-d969a1795625 | 1 | 2020-01-03 |
| 68180-892-73 | EA - Each | 68180-892 | ba094228-f68f-4688-932d-b57229946a8f | 1 | 2020-01-03 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1427301 | {7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Pirmella 7/7/7 28 Day] | BPCK | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 749852 | {7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 749852 | Eth estra-Noreth 0.035-0.5 MG (7) Oral Tablet / Eth estra-Noreth 0.035-0.75 MG (7) Oral Tablet / Eth estra-Noreth 0.035-1 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 310463 | norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 392662 | norethindrone 0.75 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 312033 | norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 1427301 | Pirmella 7/7/7 28 Day Pack | PSN | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 310463 | ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet | SCD | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 392662 | ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet | SCD | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 312033 | ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet | SCD | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 310463 | ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet | SY | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 392662 | ethinyl estradiol 35 MCG / norethindrone 0.75 MG Oral Tablet | SY | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 312033 | ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet | SY | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
| 1427301 | Pirmella 7/7/7 28 Day Pack | SY | 0c81daae-b83c-4444-9ad1-425518bf32d8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-892-13 | 68180089213 | 3 BLISTER PACK in 1 CARTON (68180-892-13) > 1 KIT in 1 BLISTER PACK (68180-892-11) | 3 blister pack | 2013-06-25 | 2021-08-31 | No | No | Current |
| 68180-892-73 | 68180089273 | 3 BLISTER PACK in 1 CARTON (68180-892-73) > 1 KIT in 1 BLISTER PACK (68180-892-71) | 3 blister pack | 2019-08-16 | 0000-00-00 | No | No | Current |