Prescription drug · ANDA
Dexamethasone 1.5 mg NDC 68047-702
Dexamethasone 1.5 mg/1 · Tablet · Oral · Larken Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68047-702-01 | 6804707020168047070201 | 100 TABLET in 1 BOTTLE (68047-702-01)Marketed from Sep 1, 2017 |
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)
- Dexamethasone 1.5 mgSuffix: 1.5 mg
- Generic name (nonproprietary)
- dexamethasone 1.5 mg
- Active ingredients
- Dexamethasone — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Larken Laboratories, Inc.NDC labeler code 68047
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201270
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68047-702_4137ff08-7529-5862-e063-6294a90aade5SPL ID 4137ff08-7529-5862-e063-6294a90aade5SPL set ID fcc75691-974e-4a67-b9d7-64dde72b5595RxCUI 197580, 759481, 759697, 846192UNII 7S5I7G3JQLUPC 0368047702012
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468047070201followed by a unit qualifier and the quantityPackage 68047-0702-01. 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 Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocort…
Excerpt only. Read the full label for complete information.
About NDC 68047-702
- What is NDC 68047-702?
- 68047-702 is the product NDC for Dexamethasone 1.5 mg, Dexamethasone 1.5 mg/1 tablet, listed with the FDA by Larken Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexamethasone 1.5 mg.
- What is the active ingredient?
- Dexamethasone.
- Who is the labeler?
- Larken Laboratories, Inc., NDC labeler code 68047. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexamethasone 1.5 mg?
- 1 other product NDC are listed under this name. See all Dexamethasone 1.5 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexamethasone 1.5 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexamethasone 1.5 mg | Dexamethasone 1.5 mg/1 | TabletOral | Proficient Rx LP | 82804-059 | 82804-0059-21 |
Other NDCs under ANDA 201270
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 |
|---|---|---|---|---|
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0346 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Proficient Rx LP | 82804-132 |
| Dexamethasone 1.5 mg | Dexamethasone 1.5 mg/1 | TabletOral | Proficient Rx LP | 82804-059 |