Hydrocortisone Valerate
- Product NDC
- 45802-455
- 11-digit product format
- 458020455
- Labeler code
- 45802
- Product ID
- 45802-455_551a3464-2ef3-4f43-8f46-f83b4a4def09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Valerate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA075666
- Marketing category
- ANDA
- Marketing start
- 2009-12-02
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE VALERATE
- Active strength
- 2 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-455-35 | GM - Gram | 45802-455 | 2b515c66-c309-4ce7-936d-f52592135aca | 1 | 2012-07-24 |
| 45802-455-37 | GM - Gram | 45802-455 | 2f532795-ef75-447c-96b9-cab69b97408b | 1 | 2012-07-24 |
| 45802-455-42 | GM - Gram | 45802-455 | 91777d4e-e930-430f-9261-0b911b77d3c4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROCORTISONE VALERATE | ACTIVE INGREDIENT | 68717P8FUZ | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE VALERATE CREAM [DIRECT RX] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1370754 | hydrocortisone valerate 0.2 % Topical Cream | PSN | 10e49e96-cffd-44ab-827c-6d2724a349db | 5 |
| 1370754 | hydrocortisone valerate 2 MG/ML Topical Cream | SCD | 10e49e96-cffd-44ab-827c-6d2724a349db | 5 |
| 1370754 | hydrocortisone valerate 0.2 % Topical Cream | SY | 10e49e96-cffd-44ab-827c-6d2724a349db | 5 |
| 1370754 | hydrocortisone valerate 0.2 % Topical Cream | PSN | f165db21-1f03-4f33-8383-196f6adda6e3 | 3 |
| 1370754 | hydrocortisone valerate 2 MG/ML Topical Cream | SCD | f165db21-1f03-4f33-8383-196f6adda6e3 | 3 |
| 1370754 | hydrocortisone valerate 0.2 % Topical Cream | SY | f165db21-1f03-4f33-8383-196f6adda6e3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-455-35 | 45802045535 | 1 TUBE in 1 CARTON (45802-455-35) > 15 g in 1 TUBE | 1 tube | 2009-12-02 | 0000-00-00 | No | No | Current |
| 45802-455-37 | 45802045537 | 1 TUBE in 1 CARTON (45802-455-37) > 60 g in 1 TUBE | 1 tube | 2009-12-11 | 0000-00-00 | No | No | Current |
| 45802-455-42 | 45802045542 | 1 TUBE in 1 CARTON (45802-455-42) > 45 g in 1 TUBE | 1 tube | 2010-02-11 | 0000-00-00 | No | No | Current |