Over-the-counter drug · NDA
RiVive (Naloxone hydrochloride) NDC 82954-0100
Naloxone hydrochloride 3 mg/.1mL · Spray · Nasal · Harm Reduction Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82954-0100-1 | 82954010001 | 2 VIAL, SINGLE-DOSE in 1 CARTON (82954-0100-1) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 2, 2024 |
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)
- RiVive
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 3 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Harm Reduction Therapeutics, Inc.NDC labeler code 82954
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217722
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 82954-0100_4e308ade-33a2-4daa-acdd-af1559b90c17SPL ID 4e308ade-33a2-4daa-acdd-af1559b90c17SPL set ID 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4dRxCUI 2673091UNII F850569PQR
- Pharmacologic class
- Opioid Antagonist
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482954010001followed by a unit qualifier and the quantityPackage 82954-0100-01. 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 .
Indications (excerpt from the label)
Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life
Excerpt only. Read the full label for complete information.
About NDC 82954-0100
- What is NDC 82954-0100?
- 82954-0100 is the product NDC for RiVive (naloxone hydrochloride), Naloxone hydrochloride 3 mg/.1mL spray, listed with the FDA by Harm Reduction Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- RiVive (Naloxone hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Harm Reduction Therapeutics, Inc., NDC labeler code 82954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for RiVive?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.