Prescription drug · ANDA
promethazine hydrochloride NDC 17856-0059
Promethazine hydrochloride 6.25 mg/5mL · Syrup · Oral · ATLANTIC BIOLOGICALS CORP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0059-1 | 17856005901 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Nov 13, 2023 |
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 — 6.25 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091675
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 17856-0059_45b43457-b9cd-09a2-e063-6294a90a698dSPL ID 45b43457-b9cd-09a2-e063-6294a90a698dSPL set ID 69934bbb-922c-4752-b253-f2f07340de8dRxCUI 992432UNII 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
N417856005901followed by a unit qualifier and the quantityPackage 17856-0059-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is 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 adjun…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091675
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 6.25 mg/5mL | SyrupOral | A-S Medication Solutions | 50090-6431 |
| promethazine hydrochloride | Promethazine hydrochloride 6.25 mg/5mL | SyrupOral | Cranbury Pharmaceuticals, LLC | 27808-051 |