Prescription drug · ANDA
scopolamine NDC 0591-2258
Scopolamine 1 mg/3d · System · Transdermal · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2258-04 | 0059122580400591225804 | 4 POUCH in 1 CARTON (0591-2258-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from May 12, 2022 | |
| 0591-2258-23 | 0059122582300591225823 | 24 POUCH in 1 CARTON (0591-2258-23) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from May 12, 2022 | |
| 0591-2258-79 | 0059122587900591225879 | 10 POUCH in 1 CARTON (0591-2258-79) / 1 PATCH in 1 POUCH / 3 d in 1 PATCHMarketed from May 12, 2022 |
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
- System
- Route
- Transdermal
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208769
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0591-2258_59f10193-3604-4f3c-a9f7-68a55004f3d0SPL ID 59f10193-3604-4f3c-a9f7-68a55004f3d0SPL set ID 800b6421-48eb-47f5-b255-c12f75e59068RxCUI 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
N400591225804followed by a unit qualifier and the quantityPackage 00591-2258-04. 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 0591-2258
- What is NDC 0591-2258?
- 0591-2258 is the product NDC for scopolamine, Scopolamine 1 mg/3d system, listed with the FDA by Actavis Pharma, 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?
- Actavis Pharma, Inc., NDC labeler code 0591. 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 | A-S Medication Solutions | 50090-7188 | 50090-7188-00 |
| Scopolamine | Scopolamine 1.5 mg/1 | Patch, Extended releaseTransdermal | Ingenus Pharmaceuticals, LLC | 50742-505 | 50742-0505-0450742-0505-1050742-0505-24 |
Other NDCs under ANDA 208769
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 | SystemTransdermal | A-S Medication Solutions | 50090-7188 |