Norethindrone Acetate and Ethinyl Estradiol
- Product NDC
- 50090-6782
- 11-digit product format
- 500906782
- Labeler code
- 50090
- Product ID
- 50090-6782_499d4f41-3e8a-46f7-a25e-74c6cf7636c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA206969
- Marketing category
- ANDA
- Marketing start
- 2016-01-20
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .02; 1 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norethindrone Acetate and Ethinyl Estradiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .02 mg/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1358762, 1358776 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6782-0 | Norethindrone Acetate and Ethinyl Estradiol | 21 in 1 BLISTER PACK | TABLET | 21 | | 7 |
| 50090-6782-0 | Norethindrone Acetate and Ethinyl Estradiol | 1 in 1 CARTON | TABLET | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6782 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, 2 package rows | 20231214_38924c83-53aa-4279-8f0e-1a5d8f5fd8ad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6782-0 | 50090678200 | 1 BLISTER PACK in 1 CARTON (50090-6782-0) / 21 TABLET in 1 BLISTER PACK | 1 blister pack | 2023-10-30 | No | No | Historical |