diltiazem hydrochloride
- Product NDC
- 43353-906
- 11-digit product format
- 433530906
- Labeler code
- 43353
- Product ID
- 43353-906_5daab746-e686-48fc-a47d-ba12ec36b88f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA020401
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-09-25
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-906-79 | diltiazem hydrochloride | 2160 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 2160 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| diltiazem hydrochloride | ACTIVE INGREDIENT | OLH94387TE | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| diltiazem | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| D&C Red no. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C Blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C Green no. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Povidone | INACTIVE INGREDIENT | FZ989GH94E | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-906 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 1 package rows | 20140529_bf56b78c-9ace-4404-9147-707d61379237.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-906-79 | 43353090679 | 2160 in 1 BOTTLE, PLASTIC | Historical |