Angeliq
- Product NDC
- 50419-482
- 11-digit product format
- 504190482
- Labeler code
- 50419
- Product ID
- 50419-482_261d4ace-5c4e-48f6-b793-354492017e89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- drospirenone and estradiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA021355
- Marketing category
- NDA
- Marketing start
- 2012-02-29
- Substance
- DROSPIRENONE; ESTRADIOL
- Active strength
- .25; .5 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Angeliq
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DROSPIRENONE | .25 mg/1 |
| ESTRADIOL | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N295J34A25, 4TI98Z838E |
| Rxcui | 1483549, 1483550, 1483551, 1483552, 1483553, 1483554 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-482-01 | Angeliq | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 20 |
| 50419-482-03 | Angeliq | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 20 |
| 50419-482-71 | Angeliq | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 20 |
| 50419-482-72 | Angeliq | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DROSPIRENONE | ACTIVE INGREDIENT | N295J34A25 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| DROSPIRENONE | ACTIVE MOIETY | N295J34A25 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-482 | ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 17 | Current NDC, Legacy NDC, 4 package rows | 20240207_761834c2-6b61-4583-84c2-f1ca4a97c4f2.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 |
|---|
| 50419-482-01 | 50419048201 | 28 in 1 BLISTER PACK | | | | | | Historical |
| 50419-482-03 | 50419048203 | 3 BLISTER PACK in 1 CARTON (50419-482-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01) | 3 blister pack | 2012-02-29 | 0000-00-00 | No | No | Current |
| 50419-482-71 | 50419048271 | 14 in 1 BLISTER PACK | | | | | | Historical |
| 50419-482-72 | 50419048272 | 1 BLISTER PACK in 1 CARTON (50419-482-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71) | 1 blister pack | 2012-02-29 | 0000-00-00 | No | No | Current |