Dicyclomine Hydrochloride
- Product NDC
- 62135-428
- 11-digit product format
- 621350428
- Labeler code
- 62135
- Product ID
- 62135-428_241f85bb-925f-a594-e063-6394a90a92fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA040230
- Marketing category
- ANDA
- Marketing start
- 1999-02-26
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICYCLOMINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991061, 991086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-428-01 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 62135-428-12 | Dicyclomine Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-428 | DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241012_d628ac1c-404d-45eb-8aab-0e550c95ed4a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-428-01 | 62135042801 | 100 TABLET in 1 BOTTLE (62135-428-01) | 100 tablet | 2023-03-13 | | No | No | Current |
| 62135-428-12 | 62135042812 | 120 TABLET in 1 BOTTLE (62135-428-12) | 120 tablet | 2022-12-05 | 0000-00-00 | No | No | Current |