Dicyclomine Hydrochloride
- Product NDC
- 55289-923
- 11-digit product format
- 552890923
- Labeler code
- 55289
- Product ID
- 55289-923_2ac0893d-8730-c60f-e063-6394a90a3c88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA085082
- Marketing category
- ANDA
- Marketing start
- 1986-06-19
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991061 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-923-20 | Dicyclomine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 32 |
| 55289-923-28 | Dicyclomine Hydrochloride | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 32 |
| 55289-923-30 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 32 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-923 | DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 32 | Current NDC, Legacy NDC, 3 package rows | 20250104_b3d591ad-4eb7-4cdf-93b2-62cd479e921b.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 |
|---|
| 55289-923-20 | 55289092320 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-20) | 20 capsule | 2017-06-22 | 0000-00-00 | No | No | Current |
| 55289-923-28 | 55289092328 | 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-28) | 28 capsule | 2015-10-09 | 0000-00-00 | No | No | Current |
| 55289-923-30 | 55289092330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-923-30) | 30 capsule | 2015-10-09 | 0000-00-00 | No | No | Current |