hydrocortisone
- Product NDC
- 45802-937
- 11-digit product format
- 458020937
- Labeler code
- 45802
- Product ID
- 45802-937_509f69b3-52e9-4505-acba-722dee4ebdf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA089074
- Marketing category
- ANDA
- Marketing start
- 2008-05-23
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 197785 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-937-16 | hydrocortisone | 59 mL in 1 BOTTLE | LOTION | 59 | | 10 |
| 45802-937-26 | hydrocortisone | 118 mL in 1 BOTTLE | LOTION | 118 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| DEHYDROACETIC ACID | INACTIVE INGREDIENT | 2KAG279R6R | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| MYRISTYL ALCOHOL | INACTIVE INGREDIENT | V42034O9PU | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| MYRISTYL LACTATE | INACTIVE INGREDIENT | 1D822OC34X | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE LOTION [PERRIGO NEW YORK INC] | 4 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| DEHYDROACETIC ACID | INACTIVE INGREDIENT | 2KAG279R6R | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MYRISTYL ALCOHOL | INACTIVE INGREDIENT | V42034O9PU | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MYRISTYL LACTATE | INACTIVE INGREDIENT | 1D822OC34X | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYOXYL 100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE LOTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-937 | HYDROCORTISONE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241222_f05b7fa6-26a9-4aca-8975-819ece891060.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 |
|---|
| 45802-937-16 | 45802093716 | 59 mL in 1 BOTTLE (45802-937-16) | 59 ml | 2008-09-24 | 0000-00-00 | No | No | Current |
| 45802-937-26 | 45802093726 | 118 mL in 1 BOTTLE (45802-937-26) | 118 ml | 2008-05-23 | 0000-00-00 | No | No | Current |