Prescription drug · ANDA
Scopolamine NDC 0378-6470
Scopolamine 1 mg/3d · Patch · Transdermal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6470-44 | 0037864704400378647044 | 24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from Jun 19, 2019 | |
| 0378-6470-97 | 0037864709700378647097 | 10 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from Jun 19, 2019 | |
| 0378-6470-99 | 0037864709900378647099 | 4 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
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- 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
N400378647044followed by a unit qualifier and the quantityPackage 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.
About NDC 0378-6470
- What is NDC 0378-6470?
- 0378-6470 is the product NDC for Scopolamine, Scopolamine 1 mg/3d patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Scopolamine.
- What is the active ingredient?
- Scopolamine.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Scopolamine?
- 13 other product NDCs are listed under this name. See all Scopolamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Scopolamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1662 | 69238-1662-0269238-1662-0469238-1662-09 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Rhodes Pharmaceuticals LLC | 42858-150 | 42858-0150-1442858-0150-4042858-0150-70 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 71335-3013 | 71335-3013-01 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 71335-3014 | 71335-3014-01 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 71335-3015 | 71335-3015-01 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-2453 | 72162-2453-0272162-2453-0472162-2453-07 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1846 | 70710-1846-0270710-1846-0470710-1846-07 |
| Scopolamine | Scopolamine 1 mg/3d | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1787 | 70771-1787-0270771-1787-0470771-1787-07 |
| scopolamine | Scopolamine 1 mg/3d | SystemTransdermal | Actavis Pharma, Inc. | 0591-2258 | 00591-2258-0400591-2258-2300591-2258-79 |
| scopolamine | Scopolamine 1 mg/3d | SystemTransdermal | A-S Medication Solutions | 50090-7188 | 50090-7188-00 |
Other NDCs under ANDA 203753
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 |
|---|---|---|---|---|
| Scopolamine | Scopolamine 1 mg/3d | PatchTransdermal | A-S Medication Solutions | 50090-5349 |