Prescription drug · ANDA
Promethazine Hydrochloride NDC 87063-016
Promethazine hydrochloride 50 mg/1 · Tablet · Oral · ASCLEMED USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87063-016-00 | 87063001600 | 1000 TABLET in 1 BOTTLE (87063-016-00)Marketed from Oct 17, 2025 | |
| 87063-016-01 | 87063001601 | 100 TABLET in 1 BOTTLE (87063-016-01)Marketed from Oct 17, 2025 | |
| 87063-016-05 | 87063001605 | 500 TABLET in 1 BOTTLE (87063-016-05)Marketed from Oct 17, 2025 | |
| 87063-016-10 | 87063001610 | 10 TABLET in 1 BOTTLE (87063-016-10)Marketed from Oct 17, 2025 | |
| 87063-016-20 | 87063001620 | 20 TABLET in 1 BOTTLE (87063-016-20)Marketed from Oct 17, 2025 | |
| 87063-016-30 | 87063001630 | 30 TABLET in 1 BOTTLE (87063-016-30)Marketed from Oct 17, 2025 | |
| 87063-016-60 | 87063001660 | 60 TABLET in 1 BOTTLE (87063-016-60)Marketed from Oct 17, 2025 | |
| 87063-016-90 | 87063001690 | 90 TABLET in 1 BOTTLE (87063-016-90)Marketed from Oct 17, 2025 |
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)
- Promethazine Hydrochloride
- Generic name (nonproprietary)
- promethazine hydrochloride
- Active ingredients
- Promethazine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ASCLEMED USA INC.NDC labeler code 87063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040596
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 87063-016_55a50d4e-813d-b1c0-e063-6394a90a4617SPL ID 55a50d4e-813d-b1c0-e063-6394a90a4617SPL set ID 4d30e587-6d59-4cf5-ab45-c7639f759df9RxCUI 992438, 992447, 992475UNII R61ZEH7I1I
- 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
N487063001600followed by a unit qualifier and the quantityPackage 87063-0016-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine Hydrochloride, is useful orally 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 co…
Excerpt only. Read the full label for complete information.
About NDC 87063-016
- What is NDC 87063-016?
- 87063-016 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 50 mg/1 tablet, listed with the FDA by ASCLEMED USA INC.. It has 8 package NDCs, 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?
- ASCLEMED USA INC., NDC labeler code 87063. 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 040596
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 12.5 mg/1 | TabletOral | American Health Packaging | 60687-660 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-015 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Sportpharm LLC | 85766-110 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Sportpharm LLC | 85766-108 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Sportpharm LLC | 85766-109 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-115 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | DIRECT RX | 72189-176 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1306 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4811 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | BluePoint Laboratories | 68001-161 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4812 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-162 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4813 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-163 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-042 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2488 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1139 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1591 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4875 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4865 |
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