Rosyrah
- Product NDC
- 70700-312
- 11-digit product format
- 707000312
- Labeler code
- 70700
- Product ID
- 70700-312_4fb6f740-69bf-590d-4474-43ff5c2e5986
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Xiromed, LLC
- Application
- ANDA206053
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rosyrah
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 238019, 248310, 1373501, 1373502, 1373503, 2705814 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70700-312-87 | Rosyrah | 1 in 1 CARTON | KIT | 1 | 2 | |
| 70700-312-87 | Rosyrah | 1 in 1 POUCH | KIT | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-312-87 | EA - Each | 70700-312 | d6f28439-a3cf-44a8-a189-e67b2919be14 | 1 | 2025-06-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2705814 | {7 (ethinyl estradiol 0.01 MG Oral Tablet) / 42 (ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack [Rosyrah 91 Day] | BPCK | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373503 | {7 (ethinyl estradiol 0.01 MG Oral Tablet) / 42 (ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack | GPCK | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373503 | Eth estra 0.01 MG (7) Oral Tablet / Eth estra-Levonorgest 0.02-0.15 MG (42) Oral Tablet / Eth estra-Levonorgest 0.025-0.15 MG (21) Oral Tablet / Eth estra-Levonorgest 0.03-0.15 MG (21) Oral Tablet 3 Month Pack | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373501 | ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373502 | ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 2705814 | Rosyrah 91 Day Pack | PSN | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373501 | ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 1373502 | ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
| 2705814 | Rosyrah 91 Day Pack | SY | d2f0af55-205f-df9c-c572-1f7b14976655 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70700-312-87 | 70700031287 | 1 POUCH in 1 CARTON (70700-312-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 1 pouch | 2025-01-29 | No | No | Current |