PIRMELLA 1/35
- Product NDC
- 68180-893
- 11-digit product format
- 681800893
- Labeler code
- 68180
- Product ID
- 68180-893_74611754-4ad2-4f50-a93e-7f001a84fe89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NORETHINDRONE AND ETHINYL ESTRADIOL
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA201512
- Marketing category
- ANDA
- Marketing start
- 2019-08-16
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-893-11 | PIRMELLA 1/35 | 1 in 1 BLISTER PACK | KIT | 1 | | 5 |
| 68180-893-13 | PIRMELLA 1/35 | 3 in 1 CARTON | KIT | 3 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ETHINYL ESTRADIOL | ACTIVE INGREDIENT | 423D2T571U | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| NORETHINDRONE | ACTIVE INGREDIENT | T18F433X4S | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ETHINYL ESTRADIOL | ACTIVE MOIETY | 423D2T571U | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-893 | PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20140108_bb21b098-284a-4cad-bf8f-a062e88a3d56.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 |
|---|
| 68180-893-11 | 68180089311 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68180-893-13 | 68180089313 | 3 BLISTER PACK in 1 CARTON (68180-893-13) > 1 KIT in 1 BLISTER PACK (68180-893-11) | 3 blister pack | 2013-06-28 | 2021-09-30 | No | No | Current |
| 68180-893-73 | 68180089373 | 3 BLISTER PACK in 1 CARTON (68180-893-73) > 1 KIT in 1 BLISTER PACK (68180-893-71) | 3 blister pack | 2019-08-16 | 0000-00-00 | No | No | Current |