norgestimate and ethinyl estradiol
- Product NDC
- 72789-435
- 11-digit product format
- 727890435
- Labeler code
- 72789
- Product ID
- 72789-435_32475b1f-ec92-8f6e-e063-6294a90aad75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA200541
- Marketing category
- ANDA
- Marketing start
- 2020-01-08
- 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 |
|---|---|---|---|---|---|---|
| 72789-435-79 | norgestimate and ethinyl estradiol | 1 in 1 BLISTER PACK | KIT | 1 | 15 | |
| 72789-435-79 | norgestimate and ethinyl estradiol | 1 in 1 POUCH | KIT | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-435-79 | EA - Each | 72789-435 | 01757e93-25ef-4457-8b3d-77cd67e8d066 | 1 | 2024-11-05 |
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 | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 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 | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 748797 | inert 1 MG Oral Tablet | PSN | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 578732 | norgestimate 0.18 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749155 | norgestimate 0.215 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749156 | norgestimate 0.25 MG / ethinyl estradiol 0.025 MG Oral Tablet | PSN | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 578732 | ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet | SCD | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749155 | ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet | SCD | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749156 | ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet | SCD | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 578732 | ethinyl estradiol 25 MCG / norgestimate 180 MCG Oral Tablet | SY | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749155 | ethinyl estradiol 25 MCG / norgestimate 215 MCG Oral Tablet | SY | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
| 749156 | ethinyl estradiol 25 MCG / norgestimate 250 MCG Oral Tablet | SY | 2385591b-70ee-0577-e063-6394a90a9357 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72789-435-79 | 72789043579 | 1 BLISTER PACK in 1 POUCH (72789-435-79) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2024-10-03 | No | No | Current |