Scopolamine
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2025-08-23
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 21:41:01
Label at a glance#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 226552 | scopolamine 1 MG 3 Day Transdermal System | PSN | 3 |
| 226552 | 72 HR scopolamine 0.0139 MG/HR Transdermal System | SCD | 3 |
| 226552 | scopolamine 0.0139 MG/HR 72 HR Transdermal Patch | SY | 3 |
| 226552 | scopolamine 0.3336 MG/Day 72 HR Transdermal Patch | SY | 3 |
| 226552 | scopolamine 1.3 MG 3 Day Transdermal System | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| SCOPOLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fe8ea78e-e1a4-44bf-a6b2-42eed76976bb | Product name | 5 | 20250218 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1787-1 | Scopolamine | 3 d in 1 PATCH | PATCH, EXTENDED RELEASE | 3 | 3 | |
| 70771-1787-1 | Scopolamine | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 3 | |
| 70771-1787-2 | Scopolamine | 10 in 1 CARTON | PATCH, EXTENDED RELEASE | 10 | 3 | |
| 70771-1787-2 | Scopolamine | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 3 | |
| 70771-1787-4 | Scopolamine | 4 in 1 CARTON | PATCH, EXTENDED RELEASE | 4 | 3 | |
| 70771-1787-7 | Scopolamine | 24 in 1 CARTON | PATCH, EXTENDED RELEASE | 24 | 3 | |
| 70771-1787-7 | Scopolamine | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Scopolamine
- POVIDONE K30
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1787 | 70771-1787-2, 70771-1787-7, 70771-1787-1, 70771-1787-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SCOPOLAMINE | DL48G20X8X | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217893-001 | SCOPOLAMINE | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217893-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | d06236e962d9… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217893-001 | SCOPOLAMINE | 1MG/72HR | SYSTEM / TRANSDERMAL | AB | 2024-08-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A217893-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A217893-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217893-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217893-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217893-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217893-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217893-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217893-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217893-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217893-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217893-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217893-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217893-001 | AB | 1 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217893-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Scopolamine | SCOPOLAMINE | Zydus Lifesciences Limited | 016df9f3-61d5-45e9-b1d6-791a5d2f26d5 | 2025-08-23 | 70771-1787-1 70771-1787-2 70771-1787-7 70771-1787-4 70771-1787 70771178702 70771178704 70771178701 70771178707 2bd0ca3f-183d-4af2-8c0e-962115d97fed 016df9f3-61d5-45e9-b1d6-791a5d2f26d5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
