Prescription drug · ANDA
Promethazine Hydrochloride NDC 68071-4544
Promethazine hydrochloride 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4544-2 | 6807145440268071454402 | 12 TABLET in 1 BOTTLE (68071-4544-2)Marketed from Aug 28, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Promethazine Hydrochloride
- Generic name (nonproprietary)
- promethazine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083426
- Marketing start
- Marketing end
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 68071-4544_2dd17384-f3a5-70d3-e063-6294a90aeb7fSPL ID 2dd17384-f3a5-70d3-e063-6294a90aeb7fSPL set ID 74834e1b-0d90-0542-e053-2991aa0aa1efRxCUI 992447UNII R61ZEH7I1IUPC 0368071454420
- Pharmacologic class
- Phenothiazine
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
N468071454402followed by a unit qualifier and the quantityPackage 68071-4544-02. 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)
INDICATIONS AND USAGE Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for c…
Excerpt only. Read the full label for complete information.
About NDC 68071-4544
- What is NDC 68071-4544?
- 68071-4544 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Promethazine Hydrochloride.
- What is the active ingredient?
- Promethazine hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Promethazine Hydrochloride?
- 116 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Promethazine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-115 | 82868-0115-20 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1043 | 67046-1043-03 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-070 | 87441-0070-01 |
| Promethazine Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1854 | 00121-1854-16 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4419 | 70518-4419-00 |
| Promethazine Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SyrupOral | Xttrium Laboratories, Inc. | 0116-4023 | 00116-4023-16 |
| Promethazine Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SyrupOral | Atlantic Biologicals Corp. | 17856-4023 | 17856-4023-01 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-1447 | 67046-1447-03 |
| Promethazine Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-016 | 81033-0016-50 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3373 | 55154-3373-00 |
Other NDCs under ANDA 083426
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 |
|---|---|---|---|---|
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-5307 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-140 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-829 |