Kurvelo
- Product NDC
- 68180-844
- 11-digit product format
- 681800844
- Labeler code
- 68180
- Product ID
- 68180-844_8f9181bf-d2bd-422c-a115-0adfaacd0c9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091408
- Marketing category
- ANDA
- Marketing start
- 2021-02-07
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kurvelo
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 238019, 748797, 748878, 1356074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68180-841-74 | Kurvelo | 21 in 1 BLISTER PACK | TABLET | 21 | 0.15 mg | 12 |
| 68180-844-73 | Kurvelo | 1 in 1 BLISTER PACK | KIT | 1 | 12 | |
| 68180-844-73 | Kurvelo | 3 in 1 CARTON | KIT | 3 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-844-11 | EA - Each | 68180-844 | 114e0bda-5a2c-4701-b597-033d51f009b1 | 1 | 2013-02-13 |
| 68180-844-13 | EA - Each | 68180-844 | 9e1c797d-0f35-443a-a5f6-087683932c7e | 1 | 2013-02-13 |
| 68180-844-71 | EA - Each | 68180-844 | a48c1470-8c3b-4e05-82be-6543d8305356 | 1 | 2020-05-08 |
| 68180-844-73 | EA - Each | 68180-844 | bf06cf9d-17a9-4356-bb8c-a6e1a6bf890a | 1 | 2020-05-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1356074 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kurvelo] | BPCK | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 748797 | inert 1 MG Oral Tablet | PSN | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 1356074 | Kurvelo 28 Day Pack | PSN | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 1356074 | Kurvelo 28 Day Pack | SY | 752f525e-1838-4058-9ab7-2c2d91f86dfd | 12 |
| 1356074 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kurvelo] | BPCK | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 1356074 | Kurvelo 28 Day Pack | PSN | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
| 1356074 | Kurvelo 28 Day Pack | SY | 51e4270a-1b91-4ff8-9a50-ffe49204b6b4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-841-74 | 68180084174 | 21 in 1 BLISTER PACK | Historical | |||||
| 68180-844-13 | 68180084413 | 3 BLISTER PACK in 1 CARTON (68180-844-13) > 1 KIT in 1 BLISTER PACK (68180-844-11) | 3 blister pack | 2012-10-29 | 2021-11-30 | No | No | Current |
| 68180-844-73 | 68180084473 | 3 BLISTER PACK in 1 CARTON (68180-844-73) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74) | 3 blister pack | 2021-02-07 | 0000-00-00 | No | No | Current |