Prescription drug · ANDA
Promethazine Hydrochloride NDC 50090-0879
Promethazine hydrochloride 50 mg/mL · Injection · Intramuscular · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0879-0 | 50090087900 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 28, 2014 |
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 — 50 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083312
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 50090-0879_5cb280fa-c45d-4dbb-8e1d-c2271db20a77SPL ID 5cb280fa-c45d-4dbb-8e1d-c2271db20a77SPL set ID c930985b-bba3-4f3a-a1ae-1d808670efdeRxCUI 992858UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450090087900followed by a unit qualifier and the quantityPackage 50090-0879-00. 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 injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. Active treatment of motion sickness. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. As an adjunct to analgesics for the control of postop…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 083312
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/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-0955 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Henry Schein, Inc. | 0404-9942 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0641-0956 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-1495 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0641-1496 |
| Phenerganpromethazine hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6082 |
| Promethazine Hci | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1247 |
| Promethazine Hci | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1248 |
| Phenerganpromethazine hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0641-6083 |
| Phenerganpromethazine hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6084 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7285 |
| Phenerganpromethazine hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0641-6085 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6208 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | ProPharma Distribution | 84549-928 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7077 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-0928 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0641-0929 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-0948 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9940 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-2861 |
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