Jinteli
- Product NDC
- 0093-3122
- 11-digit product format
- 000933122
- Labeler code
- 0093
- Product ID
- 0093-3122_ae9e248a-d907-4316-b96f-485d4769fa5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076221
- Marketing category
- ANDA
- Marketing start
- 2011-02-17
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 5; 1 ug/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Jinteli
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 5 ug/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1090992, 1090996 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-3122-28 | Jinteli | 28 in 1 BLISTER PACK | TABLET | 28 | | 12 |
| 0093-3122-42 | Jinteli | 5 in 1 CARTON | TABLET | 5 | | 12 |
| 0093-3122-98 | Jinteli | 90 in 1 BOTTLE | TABLET | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3122 | JINTELI (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS USA, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20240307_d667ca75-1a17-43fc-9077-f25ce0908f8d.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 |
|---|
| 0093-3122-28 | 00093312228 | 28 in 1 BLISTER PACK | | | | | | Historical |
| 0093-3122-42 | 00093312242 | 5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28) | 5 blister pack | 2011-02-17 | 0000-00-00 | No | No | Current |
| 0093-3122-98 | 00093312298 | 90 TABLET in 1 BOTTLE (0093-3122-98) | 90 tablet | 2011-02-17 | 0000-00-00 | No | No | Current |