Over-the-counter drug · OTC MONOGRAPH DRUG
astonea (Hydrocortisone) NDC 77338-305
Hydrocortisone acetate 10 mg/g · Cream · Topical · ASTONEA LABS PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77338-305-02 | 77338030502 | .9 g in 1 PACKET (77338-305-02)Marketed from May 2, 2022 | |
| 77338-305-03 | 77338030503 | 28.3 g in 1 TUBE (77338-305-03)Marketed from May 2, 2022 | |
| 77338-305-06 | 77338030506 | 454 g in 1 JAR (77338-305-06)Marketed from May 2, 2022 |
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)
- astonea
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone acetate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- ASTONEA LABS PRIVATE LIMITEDNDC labeler code 77338
- 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 77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320SPL ID 1bbae087-0d0a-67d2-e063-6294a90a8320SPL set ID de09e859-c5fd-0cc5-e053-2a95a90a147eRxCUI 1043690UNII 3X7931PO74
- 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
N477338030502followed by a unit qualifier and the quantityPackage 77338-0305-02. 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 temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor
Excerpt only. Read the full label for complete information.
About NDC 77338-305
- What is NDC 77338-305?
- 77338-305 is the product NDC for astonea (hydrocortisone), Hydrocortisone acetate 10 mg/g cream, listed with the FDA by ASTONEA LABS PRIVATE LIMITED. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- astonea (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone acetate.
- Who is the labeler?
- ASTONEA LABS PRIVATE LIMITED, NDC labeler code 77338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for astonea?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Rite Aid Hydrocortisonehydrocortisone 1% | Hydrocortisone 1 g/100g | OintmentTopical | Rite Aid | 11822-2685 |
| Flanaxmethyl salicylate, menthol, capsaicin | Methyl salicylate 28 g/100g + 2 more ingredients | LinimentTopical | Belmora LLC | 27854-499 |
| Profoot Pain Relief Patchescamphor, menthol, methyl salicylate | — | Kit | Rooftop Consumer Health, Inc. | 29784-600 |
| Eagle Medicatedmenthol methyl salicylate | Methyl salicylate 30 g/100mL; Menthol 14.5 g/100mL | OilTopical | Borden Company (Private) Limited | 43405-008 |
| Burn Relief Aloelidocaine hcl | Lidocaine hydrochloride 4 g/100g | GelTopical | Acutens | 80551-001 |
| Large Pain Relievingcamphor menthol methyl salicytate | Camphor (Synthetic) 3.1 g/100g + 2 more ingredients | PatchTopical | Walgreen Company | 0363-9904 |
| Teeter Renew Muscles Pain Relievingmethyl salicylate, menthol | Methyl salicylate 100 mg/mL; Menthol 70 mg/mL | CreamTopical | STL International INC | 70329-730 |
| Nufabrx Medicine Infused Sockscapsaicin | Capsaicin .12 g/100g | ClothTopical | Nufabrx LLC | 72490-037 |
| Burnlidocaine | Lidocaine hydrochloride 2 mg/100mL | SprayTopical | HART Health | 50332-0210 |
| Pramoxine Itch reliefpramoxine hcl 1% | Pramoxine hydrochloride 1 g/100g | CreamTopical | CVS | 51316-141 |
| DG Health Hydrocortisone Maximum Strengthhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Dolgencorp Inc | 55910-319 |
| Methyl Salicylate 10% Pain Relievingmethyl salicylate | Methyl salicylate 100 mg/g | CreamTopical | PureTek Corporation | 59088-243 |
| Biofreezementhol | Menthol 105 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-833 |
| Qr Painanalgesic | Mannitol 30 g/100g; Menthol 1.25 g/100g | CreamTopical | MARYHELENE ENTERPRISES INC | 73180-005 |
| Methyl Salicylate 25% Creammethyl salicylate | Methyl salicylate 250 mg/mL | CreamTopical | Medcore LLC | 82461-415 |
| Profoot Pain Relief Patchescamphor, menthol, methyl salicylate | — | Kit | Profoot, Inc. | 29784-601 |
| Lidocaineburn relief | Lidocaine .64 g/127g | Aerosol, SprayTopical | Foodhold USA | 41520-162 |
| Eagle Medicated Aromaticcamphor menthol methyl salicylate | Camphor (Synthetic) 7 g/100mL + 2 more ingredients | OilTopical | Borden Company (Private) Limited | 43405-009 |
| Hydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Unifirst First Aid Corporation | 47682-933 |
| Arctic Heatmenthol, methyl salicylate | Methyl salicylate 11.2 g/112g; Menthol 2.24 g/112g | CreamTopical | Renu Laboratories, LLC | 76348-414 |
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