Prescription drug · ANDA
Promethazine Hydrochloride NDC 70518-2488
Promethazine hydrochloride 12.5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2488-0 | 70518248800 | 30 TABLET in 1 BLISTER PACK (70518-2488-0)Marketed from Dec 17, 2019 |
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 — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-2488_4a2b8d97-b89a-6b68-e063-6394a90ab332SPL ID 4a2b8d97-b89a-6b68-e063-6394a90ab332SPL set ID adb04635-584f-4fef-98ca-2574be312a73RxCUI 992438UNII 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
N470518248800followed by a unit qualifier and the quantityPackage 70518-2488-00. 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 70518-2488
- What is NDC 70518-2488?
- 70518-2488 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 12.5 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 114 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 |
|---|---|---|---|---|
| Phenerganpromethazine hcl | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Direct_Rx | 72189-402 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-1447 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | American Health Packaging | 68084-155 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-678 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-679 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-692 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0265 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 71205-658 |
| 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8154 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-163 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | BluePoint Laboratories | 68001-161 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-162 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4809 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1139 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-040 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-041 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-042 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | American Health Packaging | 60687-660 |
Showing 20 of 39.