temazepam
- Product NDC
- 52959-459
- 11-digit product format
- 529590459
- Labeler code
- 52959
- Product ID
- 52959-459_54f020bf-54a5-4a05-98f2-c7ca8e25be3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA071457
- Marketing category
- ANDA
- Marketing start
- 1987-04-21
- Marketing end
- 0000-00-00
- Substance
- TEMAZEPAM
- Active strength
- 30 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| temazepam | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| temazepam | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| ammonia | INACTIVE INGREDIENT | 5138Q19F1X | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| butyl alcohol | INACTIVE INGREDIENT | 8PJ61P6TS3 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| potassium hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-459 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | Legacy NDC, 7 package rows | 20120423_2ed81194-be24-45a0-8dde-fbc6ad3d7abe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-459-00 | 52959045900 | 100 in 1 BOTTLE | Historical |
| 52959-459-10 | 52959045910 | 10 in 1 BOTTLE | Historical |
| 52959-459-12 | 52959045912 | 12 in 1 BOTTLE | Historical |
| 52959-459-15 | 52959045915 | 15 in 1 BOTTLE | Historical |
| 52959-459-20 | 52959045920 | 20 in 1 BOTTLE | Historical |
| 52959-459-30 | 52959045930 | 30 in 1 BOTTLE | Historical |
| 52959-459-60 | 52959045960 | 60 in 1 BOTTLE | Historical |