Prescription drug · ANDA
Promethazine Hydrochloride NDC 70518-4419
Promethazine hydrochloride 25 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70518-4419Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4419Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4419-0 | 70518441900 | 30 TABLET in 1 BLISTER PACK (70518-4419-0)Marketed from Jul 31, 2025 |
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
- 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 70518-4419_5b245bc7-a1ce-bc7d-e063-6394a90a188bSPL ID 5b245bc7-a1ce-bc7d-e063-6394a90a188b
- 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
N470518441900followed by a unit qualifier and the quantityPackage 70518-4419-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4419
- What is NDC 70518-4419?
- 70518-4419 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 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?
- 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 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 |
| Promethazine Hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2377 | 72162-2377-02 |
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 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-042 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-040 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-041 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-679 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-678 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-692 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 71205-805 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7886 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | Coupler LLC | 67046-1447 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8154 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | American Health Packaging | 68084-155 |
| Phenerganpromethazine hcl | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Direct_Rx | 72189-402 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-070 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-115 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-014 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-015 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-016 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 71205-658 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Sportpharm LLC | 85766-109 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | Sportpharm LLC | 85766-108 |
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