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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N009402-002 | DELESTROGEN | ESTRADIOL VALERATE | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | |
| N009402-003 | DELESTROGEN | ESTRADIOL VALERATE | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N009402-004 | DELESTROGEN | ESTRADIOL VALERATE | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N009402-002 | AO |
| N009402-004 | AO |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N009402-003 | DELESTROGEN | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N009402-003 | DELESTROGEN | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-003 | DELESTROGEN | 40MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-004 | DELESTROGEN | 20MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009402-002 | DELESTROGEN | 10MG/ML | INJECTABLE / INJECTION | AO | RLD, RS, Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N009402-002 | AO | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N009402-004 | AO | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N009402-002 | AO | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N009402-004 | AO | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009402-002 | AO | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009402-004 | AO | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N009402-002 | AO | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N009402-004 | AO | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009402-002 | AO | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009402-004 | AO | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009402-002 | AO | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009402-004 | AO | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009402-002 | AO | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009402-004 | AO | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009402-002 | AO | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009402-004 | AO | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-002 | AO | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-003 | AO | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009402-004 | AO | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009402-002 | AO | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009402-004 | AO | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N009402-002 | AO | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N009402-004 | AO | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-002 | AO | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-003 | AO | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009402-004 | AO | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-002 | AO | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-003 | AO | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009402-004 | AO | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009402-002 | AO | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009402-003 | AO | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009402-004 | AO | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N009402-002 | AO | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N009402-003 | AO | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N009402-004 | AO | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009402-002 | AO | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009402-003 | AO | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009402-004 | AO | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N009402-002 | AO | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N009402-003 | AO | 1 | 5d02ea3f76ae… |
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 UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OKG364O896 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8f94df9-0692-4462-a7f0-fe019a0a3f07 | Available on FDA.report |
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#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Delestrogen | ESTRADIOL VALERATE | Par Health USA, LLC | e8f94df9-0692-4462-a7f0-fe019a0a3f07 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 009402 NDA009402 42023-110 |
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 |