Prescription drug · ANDA
Promethazine Hydrochloride NDC 71205-658
Promethazine hydrochloride 25 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-658-10 | 71205065810 | 10 TABLET in 1 BOTTLE (71205-658-10)Marketed from May 5, 2022 | |
| 71205-658-12 | 71205065812 | 12 TABLET in 1 BOTTLE (71205-658-12)Marketed from Jan 4, 2023 | |
| 71205-658-20 | 71205065820 | 20 TABLET in 1 BOTTLE (71205-658-20)Marketed from Sep 27, 2022 | |
| 71205-658-30 | 71205065830 | 30 TABLET in 1 BOTTLE (71205-658-30)Marketed from May 5, 2022 | |
| 71205-658-60 | 71205065860 | 60 TABLET in 1 BOTTLE (71205-658-60)Marketed from May 5, 2022 | |
| 71205-658-90 | 71205065890 | 90 TABLET in 1 BOTTLE (71205-658-90)Marketed from May 5, 2022 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-658_f274f5be-72ff-42e5-a4ba-8d1d957375b0SPL ID f274f5be-72ff-42e5-a4ba-8d1d957375b0SPL set ID 59b906c6-2ccc-416e-b3ee-db09bf553146RxCUI 992447UNII R61ZEH7I1IUPC 0371205658106
- 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
N471205065810followed by a unit qualifier and the quantityPackage 71205-0658-10. 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.
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 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 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 | Unit Dose Solutions, Inc. | 87441-070 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | DIRECT RX | 72189-176 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4812 |
| 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 | 50090-4813 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | BluePoint Laboratories | 68001-162 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | American Health Packaging | 60687-660 |
| Promethazine Hydrochloride | Promethazine hydrochloride 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-163 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1306 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-015 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-041 |
| Promethazine Hydrochloride | Promethazine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4809 |
| Promethazine Hydrochloride | Promethazine hydrochloride 12.5 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-014 |
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