Diazepam
- Product NDC
- 55154-5554
- 11-digit product format
- 551545554
- Labeler code
- 55154
- Product ID
- 55154-5554_c55f220e-6302-450a-845a-f7780e22b97e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA070325
- Marketing category
- ANDA
- Marketing start
- 2009-11-20
- Substance
- DIAZEPAM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIAZEPAM | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q3JTX2Q7TU |
| Rxcui | 197589, 197591 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 69057c52-36b0-21c0-02d6-d697be15c03c | Product name | 4 | 20260305 |
| da74e203-d183-4c62-8511-c3ef56b5964e | Product name | 1 | 20250213 |
| 2792dd44-ff30-4712-8b05-1850c2b4d307 | Product name | 3 | 20250211 |
| 2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876 | Product name | 2 | 20250102 |
| 0f898f8b-23f1-b816-6bfe-c7f8aac7e42b | Product name | 2 | 20240529 |
| 2c487d7e-cbfc-4699-9c83-5c1c7521cde9 | Product name | 1 | 20200610 |
| 02ac201d-7ee6-00c9-f963-81bb5a506b68 | Product name | 3 | 20160816 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55154-5554-0 | Diazepam | 1 in 1 BLISTER PACK | TABLET | 1 | 18 | |
| 55154-5554-0 | Diazepam | 10 in 1 BAG | TABLET | 10 | 18 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DIAZEPAM | ACTIVE INGREDIENT | Q3JTX2Q7TU | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| DIAZEPAM | ACTIVE MOIETY | Q3JTX2Q7TU | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIAZEPAM TABLET [CARDINAL HEALTH] | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-5554 | DIAZEPAM TABLET [CARDINAL HEALTH 107, LLC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241226_ba953b22-f0cd-4be5-9e0e-178bded88727.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197589 | diazePAM 10 MG Oral Tablet | PSN | ba953b22-f0cd-4be5-9e0e-178bded88727 | 18 |
| 197591 | diazePAM 5 MG Oral Tablet | PSN | ba953b22-f0cd-4be5-9e0e-178bded88727 | 18 |
| 197589 | diazepam 10 MG Oral Tablet | SCD | ba953b22-f0cd-4be5-9e0e-178bded88727 | 18 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | ba953b22-f0cd-4be5-9e0e-178bded88727 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-5554-0 | 55154555400 | 10 BLISTER PACK in 1 BAG (55154-5554-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2009-11-20 | 0000-00-00 | No | No | Current |