Myzilra
- Product NDC
- 76413-116
- 11-digit product format
- 764130116
- Labeler code
- 76413
- Product ID
- 76413-116_a6a5ef37-d5c0-4c6f-b9d5-7396f956679c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Central Texas Community Health Centers
- Application
- ANDA077502
- Marketing category
- ANDA
- Marketing start
- 2012-01-12
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-116-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5401-f424-e053-dadaa90a57ce | Myzilra ® (levonorgestrel and ethinyl estradiol tablets USP)—TRIPHASIC REGIMEN Rx only Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-116-28 | Myzilra | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1241901 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Myzilra 28 Day] | BPCK | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 748832 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 748832 | Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 1241901 | Myzilra 28 Day Pack | PSN | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | SCD | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | SCD | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | SCD | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348804 | ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet | SY | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 348805 | ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet | SY | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
| 1241901 | Myzilra 28 Day Pack | SY | 5f40763f-c0c1-44a3-a6c0-b7fe59b7d88f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 76413-116-28 | 76413011628 | 1 in 1 CARTON | Historical |