Over-the-counter drug · OTC MONOGRAPH DRUG
Hydrocortisone (Hydrocortisone 1%) NDC 11383-268
Hydrocortisone 1 g/100g · Ointment · Topical · Weeks & Leo Co., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11383-268-01 | 1138302680111383026801 | 28 g in 1 TUBE (11383-268-01)Marketed from Oct 1, 2023 | |
| 11383-268-02 | 1138302680211383026802 | 59 g in 1 TUBE (11383-268-02)Marketed from Oct 1, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydrocortisone
- Generic name (nonproprietary)
- hydrocortisone 1%
- Active ingredients
- Hydrocortisone — 1 g/100g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Weeks & Leo Co., Inc.NDC labeler code 11383
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 11383-268_0c5325e3-4797-856c-e063-6394a90a1f90SPL ID 0c5325e3-4797-856c-e063-6394a90a1f90SPL set ID 0c5325e3-4796-856c-e063-6394a90a1f90RxCUI 203105UNII WI4X0X7BPJ
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411383026801followed by a unit qualifier and the quantityPackage 11383-0268-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis poison ivy, poison oak, and poison sumac psoriasis insect bites cosmetics jewelry detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advise and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 11383-268
- What is NDC 11383-268?
- 11383-268 is the product NDC for Hydrocortisone (hydrocortisone 1%), Hydrocortisone 1 g/100g ointment, listed with the FDA by Weeks & Leo Co., Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone (Hydrocortisone 1%).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Weeks & Leo Co., Inc., NDC labeler code 11383. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocortisone?
- 168 other product NDCs are listed under this name. See all Hydrocortisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 1 g/100g | LotionTopical | Amazon.com Services LLC | 72288-469 | 72288-0469-25 |
| Hydrocortisone | Hydrocortisone 5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-892 | 43547-0892-05 |
| Hydrocortisone | Hydrocortisone 10 mg/1 | TabletOral | Solco Healthcare LLC | 43547-893 | 43547-0893-10 |
| Hydrocortisone | Hydrocortisone 20 mg/1 | TabletOral | Solco Healthcare LLC | 43547-894 | 43547-0894-10 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Amazon.com Services LLC | 72288-713 | 72288-0713-64 |
| Hydrocortisone | Hydrocortisone 25 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-065 | 21922-0065-0521922-0065-30 |
| Hydrocortisone | Hydrocortisone 20 mg/g | GelTopical | Redmont Pharmaceuticals, LLC | 71741-455 | 71741-0455-31 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Sportpharm LLC | 85766-166 | 85766-0166-1085766-0166-25 |
| hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Sportpharm LLC | 85766-151 | 85766-0151-28 |
| Hydrocortisonehydrocortisone cream 1% | Hydrocortisone 1 g/100g | CreamTopical | Aldermed Inc. | 87236-004 | 87236-0004-09 |
Other NDCs under M 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patchmenthol | Menthol .05 g/g | PatchTopical | Guangzhou Zhupuyou E-commerce Co., Ltd | 84165-004 |
| Subleef NUMBINGlidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-052 |
| Richtofit Rapid Active Arthritismenthol and camphor | Menthol 5 g/100g; Camphor (Synthetic) 4 g/100g | GelTopical | RICHTOFIT LIMITED LIABILITY COMPANY | 87384-058 |
| Meijer Pain Relief Patcheslidocaine | Lidocaine 4 g/100g | PatchTopical | Meijer Distribution Inc | 41250-625 |
| Anti Itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | HyVee Inc | 42507-319 |
| Praxpramoxine hydrochloride | Pramoxine hydrochloride 10 mg/mL | LotionTopical | AvPAK | 50268-682 |
| Itch Reliefdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 2 g/100g; Zinc acetate .1 g/100g | CreamTopical | CVS Pharmacy | 59779-708 |
| Instaflex Pain Relief Creammenthol | Menthol 12.5 mg/g | CreamTopical | Healthy Directions, LLC | 70015-665 |
| Lidocaine Pain Relief Gel Roll-Onlidocaine | Menthol .01 g/mL; Lidocaine .04 g/mL | GelTopical | Guangzhou Zhupuyou E-commerce Co., Ltd | 84165-003 |
| Pain Reliefmenthol methysalicylate | Menthol 10 g/100g; Methyl salicylate 15 g/100g | CreamTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-013 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skinhydrocortisone | Hydrocortisone .5 g/100g | CreamTopical | AmerisourceBergen | 24385-190 |
| Outgrobenzocaine | Benzocaine 18.6 g/100mL | LiquidTopical | Medtech Products Inc. | 63029-531 |
| Zensalidocaine | Lidocaine 4 g/100g | CreamTopical | Alera Skin Care Products Inc. | 69805-788 |
| Human Science Muscle Pain Reliefmethyl salicylate, menthol | Methyl salicylate 100 mg/mL; Menthol 100 mg/mL | CreamTopical | Human Science, LLC | 71356-818 |
| BiteMD External Analgesic First Aid Antisepticbenzocaine, camphor (synthetic), and phenol | Benzocaine .0524 mg/mL + 2 more ingredients | LiquidTopical | United Industries Corporation | 79364-0932 |
| Arctic Icementhol | Menthol 1.25 g/100g | GelTopical | PRIMAL ELEMENTS | 80801-105 |
| Stalliondelay creme | Benzocaine 5 g/100mL | CreamTopical | Novelties by Nasswalk, Inc. | 83608-100 |
| MedFreeze Naturally Cool Pain Reliefmenthol | Menthol 120 mg/mL | LiquidTopical | MEDKO LLC | 84443-487 |
| Hemp Magic Fast-Acting Pain Relief Creammenthol | Menthol 3 g/100g | CreamTopical | Nexxus Capital LLC | 85294-001 |
| Zkbb Arthritis Pain Reliefmethyl salicylate, camphor and capsaicin | Methyl salicylate 10 g/100g + 2 more ingredients | CreamTopical | Guchutang Biotechnology (Longyan) Co.,Ltd. | 87083-016 |
Showing 20 of 40.