Diltiazem Hydrochloride
- Product NDC
- 53217-006
- 11-digit product format
- 532170006
- Labeler code
- 53217
- Product ID
- 53217-006_6947b532-323d-413d-b76d-7ea159b285b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090492
- Marketing category
- ANDA
- Marketing start
- 2011-10-31
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 120 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 |
|---|
| 53217-006-30 | Diltiazem Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 1 |
| 53217-006-60 | Diltiazem Hydrochloride | 60 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
| 53217-006-90 | Diltiazem Hydrochloride | 90 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 90 | | 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 [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ACETYLTRIBUTYL CITRATE | INACTIVE INGREDIENT | 0ZBX0N59RZ | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE B | INACTIVE INGREDIENT | 161H3B14U2 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ETHYLCELLULOSE (20 MPA.S) | INACTIVE INGREDIENT | BJG0S321QY | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-006 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20140214_fa2891a9-b343-4071-aff1-00cf7e0f2992.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-006-30 | 53217000630 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 53217-006-60 | 53217000660 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 53217-006-90 | 53217000690 | 90 in 1 BOTTLE, PLASTIC | Historical |