Hailey 1.5/30
- Product NDC
- 68462-504
- 11-digit product format
- 684620504
- Labeler code
- 68462
- Product ID
- 68462-504_299fb286-ee60-4950-8315-d310c6ce29cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA209297
- Marketing category
- ANDA
- Marketing start
- 2018-06-05
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .03; 1.5 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
- Hailey 1.5/30
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .03 mg/1 |
| NORETHINDRONE ACETATE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1359022, 1359028, 2047760 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-504-79 | Hailey 1.5/30 | 1 in 1 POUCH | TABLET | 1 | | 9 |
| 68462-504-79 | Hailey 1.5/30 | 21 in 1 BLISTER PACK | TABLET | 21 | | 9 |
| 68462-504-81 | Hailey 1.5/30 | 3 in 1 CARTON | TABLET | 3 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-504 | HAILEY 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240612_021df70a-0c37-4237-a2f7-2597ff6d41f5.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 |
|---|
| 68462-504-79 | 68462050479 | 1 in 1 POUCH | | | | | | Historical |
| 68462-504-81 | 68462050481 | 3 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2018-06-05 | 0000-00-00 | No | No | Current |