Delestrogen
- Product NDC
- 42023-110
- 11-digit product format
- 420230110
- Labeler code
- 42023
- Product ID
- 42023-110_58569bae-90e9-492c-a026-9a7b8797b3b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol valerate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Par Health USA, LLC
- Application
- NDA009402
- Marketing category
- NDA
- Marketing start
- 2007-11-01
- Substance
- ESTRADIOL VALERATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Delestrogen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL VALERATE | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | OKG364O896 |
| Rxcui | 206620, 206715, 310189, 310190 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42023-110-01 | Delestrogen | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42023-110-01 | ML - Milliliter | 42023-110 | fac081c5-2a6a-4e15-9b71-1896f33c477a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| estradiol valerate | ACTIVE INGREDIENT | OKG364O896 | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| estradiol | ACTIVE MOIETY | 4TI98Z838E | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| benzyl benzoate | INACTIVE INGREDIENT | N863NB338G | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| castor oil | INACTIVE INGREDIENT | D5340Y2I9G | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| chlorobutanol | INACTIVE INGREDIENT | HM4YQM8WRC | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 | |
| sesame oil | INACTIVE INGREDIENT | QX10HYY4QV | DELESTROGEN (ESTRADIOL VALERATE) INJECTION [PAR PHARMACEUTICAL INC.] | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206620 | DELESTROGEN 10 MG/ML Injectable Solution | PSN | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 206715 | DELESTROGEN 20 MG/ML Injectable Solution | PSN | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 310189 | estradiol valerate 10 MG/ML Injectable Solution | PSN | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 310190 | estradiol valerate 20 MG/ML Injectable Solution | PSN | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 206620 | estradiol valerate 10 MG/ML Injectable Solution [Delestrogen] | SBD | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 206715 | estradiol valerate 20 MG/ML Injectable Solution [Delestrogen] | SBD | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 310189 | estradiol valerate 10 MG/ML Injectable Solution | SCD | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 310190 | estradiol valerate 20 MG/ML Injectable Solution | SCD | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 206620 | Delestrogen 10 MG/ML Injectable Solution | SY | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
| 206715 | Delestrogen 20 MG/ML Injectable Solution | SY | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 29 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42023-110-01 | 42023011001 | 5 mL in 1 VIAL, MULTI-DOSE (42023-110-01) | 5 ml | 2007-11-01 | 0000-00-00 | No | No | Current |