DIAZEPAM
- Product NDC
- 61919-088
- 11-digit product format
- 619190088
- Labeler code
- 61919
- Product ID
- 61919-088_9c937288-18b5-561d-e053-2995a90ab7a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIAZEPAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA071135
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- Marketing end
- 0000-00-00
- Substance
- DIAZEPAM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-088-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ba64-a426-e053-dadaa90af4c2 | DIAZEPAM C-IV 5mg |
| 61919-088-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3be2-a910-e053-dadaa90a0b85 | DIAZEPAM C-IV 5mg |
| 61919-088-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-056d-f424-e053-dadaa90a57ce | DIAZEPAM C-IV 5mg |
| 61919-088-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-056d-f424-e053-dadaa90a57ce | DIAZEPAM C-IV 5mg |
| 61919-088-72 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-056d-f424-e053-dadaa90a57ce | DIAZEPAM C-IV 5mg |
| 61919-088-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-056d-f424-e053-dadaa90a57ce | DIAZEPAM C-IV 5mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-088-03 | DIAZEPAM | 3 in 1 BOTTLE | TABLET | 3 | 2 | |
| 61919-088-02 | DIAZEPAM | 2 in 1 BOTTLE | TABLET | 2 | 1 | |
| 61919-088-30 | DIAZEPAM | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 61919-088-60 | DIAZEPAM | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 61919-088-72 | DIAZEPAM | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 61919-088-90 | DIAZEPAM | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-088-02 | EA - Each | 61919-088 | 97f5a829-6ff9-4a73-acf2-fdc4f9d4722d | 1 | 2019-08-06 |
| 61919-088-03 | EA - Each | 61919-088 | 815a9f82-6709-4d7d-af20-b401d9ac5ae9 | 1 | 2019-08-06 |
| 61919-088-30 | EA - Each | 61919-088 | 91ddad59-3b39-4ee3-860c-df871eecbc91 | 1 | 2017-08-11 |
| 61919-088-60 | EA - Each | 61919-088 | d272bba3-1399-4803-b8d2-d4d77d3c7740 | 1 | 2017-12-14 |
| 61919-088-72 | EA - Each | 61919-088 | d57dc3cc-58c7-4abb-9d20-afcc9aad43cf | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-088 | DIAZEPAM TABLET [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20200121_8d573383-ff68-5771-e053-2a95a90acdf4.zip |
| 61919-088 | DIAZEPAM TABLET [DIRECT RX] | 1 | Legacy NDC, 4 package rows | 20170307_4a2a1a9d-1ebd-5b90-e054-00144ff8d46c.zip |
| 61919-088 | DIAZEPAM TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190711_8d564803-7f5a-a2dc-e053-2a95a90a30d9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197591 | diazePAM 5 MG Oral Tablet | PSN | 8d573383-ff68-5771-e053-2a95a90acdf4 | 2 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | 8d573383-ff68-5771-e053-2a95a90acdf4 | 2 |
| 197591 | diazePAM 5 MG Oral Tablet | PSN | 4a2a1a9d-1ebd-5b90-e054-00144ff8d46c | 1 |
| 197591 | diazePAM 5 MG Oral Tablet | PSN | 8d564803-7f5a-a2dc-e053-2a95a90a30d9 | 1 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | 4a2a1a9d-1ebd-5b90-e054-00144ff8d46c | 1 |
| 197591 | diazepam 5 MG Oral Tablet | SCD | 8d564803-7f5a-a2dc-e053-2a95a90a30d9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-088-02 | 61919008802 | 2 in 1 BOTTLE | Historical | |||||
| 61919-088-03 | 61919008803 | 3 TABLET in 1 BOTTLE (61919-088-03) | 3 tablet | 2019-07-10 | 0000-00-00 | No | No | Current |
| 61919-088-30 | 61919008830 | 30 in 1 BOTTLE | Historical | |||||
| 61919-088-60 | 61919008860 | 60 in 1 BOTTLE | Historical | |||||
| 61919-088-72 | 61919008872 | 120 in 1 BOTTLE | Historical | |||||
| 61919-088-90 | 61919008890 | 90 in 1 BOTTLE | Historical |