temazepam
- Product NDC
- 52959-535
- 11-digit product format
- 529590535
- Labeler code
- 52959
- Product ID
- 52959-535_54f020bf-54a5-4a05-98f2-c7ca8e25be3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA071456
- Marketing category
- ANDA
- Marketing start
- 1987-04-21
- Marketing end
- 0000-00-00
- Substance
- TEMAZEPAM
- Active strength
- 15 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 |
|---|
| CHOLINE | ACTIVE INGREDIENT | N91BDP6H0X | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| CHOLINE | ACTIVE MOIETY | N91BDP6H0X | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | |
| 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 |
|---|
| 52959-535 | STRAZEPAM (TEMAZEPAM, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC] | 17 | Legacy NDC | 20110812_a4231f67-6c04-4ce6-8c3d-6db52afaadbe.zip |
| 52959-535 | TEMAZEPAM CAPSULE [H.J. HARKINS COMPANY, INC.] | 4 | Legacy NDC, 9 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 |
|---|
| 52959-535-10 | 52959053510 | 10 in 1 BOTTLE | Historical |
| 52959-535-12 | 52959053512 | 121 in 1 BOTTLE | Historical |
| 52959-535-15 | 52959053515 | 15 in 1 BOTTLE | Historical |
| 52959-535-20 | 52959053520 | 20 in 1 BOTTLE | Historical |
| 52959-535-24 | 52959053524 | 24 in 1 BOTTLE | Historical |
| 52959-535-28 | 52959053528 | 28 in 1 BOTTLE | Historical |
| 52959-535-30 | 52959053530 | 30 in 1 BOTTLE | Historical |
| 52959-535-40 | 52959053540 | 40 in 1 BOTTLE | Historical |
| 52959-535-60 | 52959053560 | 60 in 1 BOTTLE | Historical |