Enpresse
- Product NDC
- 21695-855
- 11-digit product format
- 216950855
- Labeler code
- 21695
- Product ID
- 21695-855_6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075809
- Marketing category
- ANDA
- Marketing start
- 2010-12-20
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-855-01 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48ae-48b1-e053-8cdaa90a720a | ENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-855-01 | Enpresse | 6 in 1 CARTON | KIT | 6 | 1 | |
| 21695-855-01 | Enpresse | 1 in 1 POUCH | KIT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-855-01 | EA - Each | 21695-855 | 7e7aa468-3287-4d2b-8980-4118587624d6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 761977 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Enpresse 28 Day] | BPCK | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748832 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 761977 | Enpresse 28 Day Triphasic Pack | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748832 | Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 761977 | Enpresse 28 Day Pack | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-855-01 | 21695085501 | 6 in 1 CARTON | Historical |