Prescription drug · ANDA
Zolpidem tartrate sublingual NDC 49884-898
Zolpidem tartrate 1.75 mg/1 · Tablet · Sublingual · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-898-11 | 49884089811 | 30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52)Marketed from Sep 11, 2017 |
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)
- Zolpidem tartrate sublingual
- Generic name (nonproprietary)
- zolpidem tartrate sublingual
- Active ingredients
- Zolpidem tartrate — 1.75 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204229
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 49884-898_8b73c0fb-c016-45f2-ab42-78d4225b6cf3SPL ID 8b73c0fb-c016-45f2-ab42-78d4225b6cf3SPL set ID 44b34e58-114b-4774-9fab-4b188dfe0228RxCUI 1232194, 1232202UNII WY6W63843KUPC 0349884899110
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Positive Modulator
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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449884089811followed by a unit qualifier and the quantityPackage 49884-0898-11. 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)
Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Us e: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem tartrate sublingual tablets are a GABA A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep Limitation of Use : Not indicated for the treatment of middle-of-the night awakening when the pati…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204229
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 |
|---|---|---|---|---|
| Zolpidem tartrate sublingual | Zolpidem tartrate 3.5 mg/1 | TabletSublingual | Par Health USA, LLC | 49884-899 |