NDC codes

FDA NDC Directory
Product NDC (as listed)49884-898Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0898Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49884-898-11498840898114988408981130 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, LLCNDC labeler code 49884
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

N449884089811 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 49884-898

What is NDC 49884-898?
49884-898 is the product NDC for Zolpidem tartrate sublingual, Zolpidem tartrate 1.75 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zolpidem tartrate sublingual.
What is the active ingredient?
Zolpidem tartrate.
Who is the labeler?
Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zolpidem tartrate sublingual?
1 other product NDC are listed under this name. See all Zolpidem tartrate sublingual NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zolpidem tartrate sublingual NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Zolpidem tartrate sublingualZolpidem tartrate 3.5 mg/1TabletSublingualPar Health USA, LLC49884-89949884-0899-11

Other NDCs under ANDA 204229

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204229
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem tartrate sublingualZolpidem tartrate 3.5 mg/1TabletSublingualPar Health USA, LLC49884-899

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in