Norgestimate and Ethinyl Estradiol
- Product NDC
- 42291-565
- 11-digit product format
- 422910565
- Labeler code
- 42291
- Product ID
- 42291-565_0e9925c8-d7f8-5cea-e063-6294a90a50a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- AvKARE
- Application
- ANDA091232
- Marketing category
- ANDA
- Marketing start
- 2020-04-20
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norgestimate and Ethinyl Estradiol
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 578732, 748797, 749155, 749156, 749157 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-565-28 | Norgestimate and Ethinyl Estradiol | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 42291-565-28 | Norgestimate and Ethinyl Estradiol | 3 in 1 CARTON | KIT | 3 | 3 | |
| 42291-565-84 | Norgestimate and Ethinyl Estradiol | 1 in 1 CARTON | KIT | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-565-28 | EA - Each | 42291-565 | bcfe4781-d7e4-4ca2-880c-e5a2b2847a36 | 1 | 2020-05-08 |
| 42291-565-84 | EA - Each | 42291-565 | 0cc2ce52-c8b7-4ef5-93be-bd42610e9ad2 | 1 | 2020-05-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749157 | {7 (ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749157 | eth estra-norgestim 0.025-0.18 MG (7) Oral Tablet / eth estra-norgestim 0.025-0.215 MG (7) Oral Tablet / eth estra-norgestim 0.025-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 748797 | inert 1 MG Oral Tablet | PSN | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 578732 | norgestimate 0.18 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749155 | norgestimate 0.215 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749156 | norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 578732 | ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet | SCD | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749155 | ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet | SCD | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749156 | ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet | SCD | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 578732 | ethinyl estradiol 25 MCG / norgestimate 180 MCG Oral Tablet | SY | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749155 | ethinyl estradiol 25 MCG / norgestimate 215 MCG Oral Tablet | SY | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
| 749156 | ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet | SY | a3ce752d-58df-363d-e053-2a95a90a5411 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42291-565-28 | 42291056528 | 1 in 1 BLISTER PACK | Historical | |||||
| 42291-565-84 | 42291056584 | 1 CARTON in 1 CARTON (42291-565-84) / 3 BLISTER PACK in 1 CARTON (42291-565-28) / 1 KIT in 1 BLISTER PACK | 1 carton | 2020-04-20 | 0000-00-00 | No | No | Current |