Scopolamine
- Product NDC
- 50090-8154
- 11-digit product format
- 500908154
- Labeler code
- 50090
- Product ID
- 50090-8154_e0c7d13d-cd47-4bfe-9814-108f4a4c048c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Scopolamine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA217893
- Marketing category
- ANDA
- Marketing start
- 2024-09-05
- Substance
- SCOPOLAMINE
- Active strength
- 1 mg/3d
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Scopolamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SCOPOLAMINE | 1 mg/3d |
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 Pharmaceuticals USA Inc. | 62d8332e-b8d2-4d13-8071-978d57e51928 | 2025-08-23 | Warnings, Adverse reactions | 217893 ANDA217893 |
| Scopolamine | SCOPOLAMINE | Zydus Lifesciences Limited | 016df9f3-61d5-45e9-b1d6-791a5d2f26d5 | 2025-08-23 | 217893 ANDA217893 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-8154-0 | 50090815400 | 4 POUCH in 1 CARTON (50090-8154-0) / 1 d in 1 POUCH | 4 pouch | 2026-10-13 | No | No | Current |