MonoNessa
- Product NDC
- 76413-166
- 11-digit product format
- 764130166
- Labeler code
- 76413
- Product ID
- 76413-166_e8facd65-2890-43f7-82fb-58181e9b9a8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Central Texas Community Health Centers
- Application
- NDA019653
- Marketing category
- NDA
- Marketing start
- 2003-01-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-166-28 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4269-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use MonoNessa or TriNessa safely and effectively. See full prescribing information for MonoNessa and TriNessa. MonoNessa ® and TriNessa ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-166-28 | MonoNessa | 1 in 1 CARTON | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 762003 | {21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [MonoNessa 28 Day] | BPCK | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 749860 | {21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 749860 | Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 748797 | inert 1 MG Oral Tablet | PSN | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 762003 | MonoNessa 28 Day Pack | PSN | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
| 762003 | MonoNessa 28 Day Pack | SY | 8a2c68c4-9cf9-48c5-9b97-e38e7c5e0a03 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 76413-166-28 | 76413016628 | 1 in 1 CARTON | Historical |