Prescription drug · NDA
Betamethasone Dipropionate NDC 0168-0055
Betamethasone dipropionate .5 mg/g · Cream · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0055-15 | 0016800551500168005515 | 1 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBEMarketed from Jun 26, 1984 | |
| 0168-0055-46 | 0016800554600168005546 | 1 TUBE in 1 CARTON (0168-0055-46) / 45 g in 1 TUBEMarketed from Jun 26, 1984 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Betamethasone Dipropionate
- Generic name (nonproprietary)
- betamethasone dipropionate
- Active ingredients
- Betamethasone dipropionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019137
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0055_f6ba8e39-dbb3-4b79-ad31-707ecc1be9f3SPL ID f6ba8e39-dbb3-4b79-ad31-707ecc1be9f3SPL set ID 97dde5f5-a865-4af2-b562-8da72c8475f3RxCUI 238920, 240209UNII 826Y60901UUPC 0301680055466, 0301680056159
- 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
N400168005515followed by a unit qualifier and the quantityPackage 00168-0055-15. 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: Topical corticosteroids are 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 0168-0055
- What is NDC 0168-0055?
- 0168-0055 is the product NDC for Betamethasone Dipropionate, Betamethasone dipropionate .5 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betamethasone Dipropionate.
- What is the active ingredient?
- Betamethasone dipropionate.
- Who is the labeler?
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betamethasone Dipropionate?
- 53 other product NDCs are listed under this name. See all Betamethasone Dipropionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betamethasone Dipropionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | CreamTopical | Aurobindo Pharma Limited | 59651-891 | 59651-0891-1459651-0891-46 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/mL | Lotion, AugmentedTopical | Encube Ethicals, Inc. | 21922-104 | 21922-0104-0121922-0104-21 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | Ointment, AugmentedTopical | Burel Pharmaceuticals, LLC | 35573-107 | 35573-0107-1535573-0107-49 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-4187 | 70518-4187-00 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | Ointment, AugmentedTopical | Aurobindo Pharma Limited | 59651-699 | 59651-0699-1459651-0699-4659651-0699-50 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-9323 | 63629-9323-01 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-9324 | 63629-9324-01 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Padagis Israel Pharmaceuticals Ltd | 45802-505 | 45802-0505-1445802-0505-84 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2715 | 71335-2715-01 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1415 | 72162-1415-0272162-1415-04 |
Other NDCs under NDA 019137
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 |
|---|---|---|---|---|
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-0235 |
| Betamethasone Dipropionate | Betamethasone dipropionate .5 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-4187 |