Dicyclomine Hydrochloride
- Product NDC
- 10135-520
- 11-digit product format
- 101350520
- Labeler code
- 10135
- Product ID
- 10135-520_ba728862-72a2-430d-e053-2a95a90aabaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA084285
- Marketing category
- ANDA
- Marketing start
- 2007-10-01
- Marketing end
- 0000-00-00
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10135-520-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-05 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-10 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-01 | 2021-02-04 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-05 | 2021-02-04 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-10 | 2021-02-04 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
| 10135-520-10 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-570f-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-520-01 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 10135-520-05 | Dicyclomine Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
| 10135-520-10 | Dicyclomine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-520 | DICYCLOMINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS INC] | 2 | Legacy NDC, 3 package rows | 20210205_0640c9b1-0207-4276-aa1f-d1db721b05ed.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 |
|---|
| 10135-520-01 | 10135052001 | 100 CAPSULE in 1 BOTTLE (10135-520-01) | 100 capsule | 2007-10-01 | 0000-00-00 | No | No | Current |
| 10135-520-05 | 10135052005 | 500 CAPSULE in 1 BOTTLE (10135-520-05) | 500 capsule | 2007-10-01 | 0000-00-00 | No | No | Current |
| 10135-520-10 | 10135052010 | 1000 CAPSULE in 1 BOTTLE (10135-520-10) | 1000 capsule | 2007-10-01 | 0000-00-00 | No | No | Current |