NDC codes

FDA NDC Directory
Product NDC (as listed)0378-6470Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-6470Add 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
0378-6470-440037864704424 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from Jun 19, 2019
0378-6470-970037864709710 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from Jun 19, 2019
0378-6470-99003786470994 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCHMarketed from Jun 19, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Scopolamine
Generic name (nonproprietary)
scopolamine
Active ingredients
Scopolamine — 1 mg/3d
Dosage form
Patch
Route
Transdermal
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203753
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 0378-6470_79930eea-4bac-4412-871f-5cd0933bef05SPL ID 79930eea-4bac-4412-871f-5cd0933bef05SPL set ID 163accb7-45e6-4d97-844d-72b606677008RxCUI 226552UNII DL48G20X8X
Pharmacologic class
Anticholinergic

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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378647044 followed by a unit qualifier and the quantity

Package 00378-6470-44. 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)

Scopolamine transdermal system is indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. ( 1 ) • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203753

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

FDA NDC Directory listings under ANDA 203753
ProductStrengthForm · routeLabelerProduct NDC
ScopolamineScopolamine 1 mg/3dPatchTransdermalA-S Medication Solutions50090-5349

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