Prescription drug · ANDA
Hydrocortisone (Hydrocortisone lotion) NDC 71297-010
Hydrocortisone 20 mg/mL · Lotion · Topical · Allegis Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71297-010-01 | 7129700100171297001001 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATORMarketed from Jun 10, 2024 | |
| 71297-010-02 | 7129700100271297001002 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (71297-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATORMarketed from Jun 10, 2024 |
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 lotion
- Active ingredients
- Hydrocortisone — 20 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Allegis Holdings LLCNDC labeler code 71297
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083231
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71297-010_561ef081-6571-b3d1-e063-6394a90a5bc7SPL ID 561ef081-6571-b3d1-e063-6394a90a5bc7SPL set ID 1a27d8fa-4025-ed68-e063-6394a90a4f37RxCUI 197784UNII WI4X0X7BPJUPC 0371297010028, 0371297010011
- 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
N471297001001followed by a unit qualifier and the quantityPackage 71297-0010-01. 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)
INDICATIONS AND USAGE Hydrocortisone Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 71297-010
- What is NDC 71297-010?
- 71297-010 is the product NDC for Hydrocortisone (hydrocortisone lotion), Hydrocortisone 20 mg/mL lotion, listed with the FDA by Allegis Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone (Hydrocortisone Lotion).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Allegis Holdings LLC, NDC labeler code 71297. 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?
- 171 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 ANDA 083231
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 |
|---|---|---|---|---|
| Ala-Scalphydrocortisone | Hydrocortisone 20 mg/mL | LotionTopical | Derm Ventures LLC | 77052-010 |