Norethindrone Acetate and Ethinyl Estradiol
- Product NDC
- 68462-656
- 11-digit product format
- 684620656
- Labeler code
- 68462
- Product ID
- 68462-656_bc4774d0-9902-4678-af65-69d6a70d9983
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA203038
- Marketing category
- ANDA
- Marketing start
- 2015-04-02
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 2.5; .5 ug/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 | 2.5 ug/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1090992, 1251323, 1251334, 1251336 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-656-29 | Norethindrone Acetate and Ethinyl Estradiol | 3 in 1 CARTON | TABLET | 3 | | 6 |
| 68462-656-29 | Norethindrone Acetate and Ethinyl Estradiol | 1 in 1 POUCH | TABLET | 1 | | 6 |
| 68462-656-90 | Norethindrone Acetate and Ethinyl Estradiol | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-656 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, Legacy NDC, 3 package rows | 20231202_cf549b5a-2707-4020-9f94-dab1260e1664.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-656-29 | 68462065629 | 3 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK | 3 pouch | 2015-04-02 | 0000-00-00 | No | No | Current |
| 68462-656-90 | 68462065690 | 90 TABLET in 1 BOTTLE (68462-656-90) | 90 tablet | 2015-04-02 | 0000-00-00 | No | No | Current |