Lisinopril and hydrochlorothiazide
- Product NDC
- 68071-3008
- 11-digit product format
- 680713008
- Labeler code
- 68071
- Product ID
- 68071-3008_1d788f31-9c44-5af1-e063-6394a90a0a5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCarePharmaceuticals, Inc.
- Application
- ANDA076194
- Marketing category
- ANDA
- Marketing start
- 2003-03-01
- Substance
- HYDROCHLOROTHIAZIDE; LISINOPRIL
- Active strength
- 12.5; 10 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lisinopril and hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| LISINOPRIL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, E7199S1YWR |
| Rxcui | 197885 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3008-3 | 2023-07-12 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-6 | 2023-07-12 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-9 | 2023-07-12 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-3 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-6 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-9 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
| 68071-3008-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1b8f-a910-e053-dadaa90a0b85 | Lisinopril and Hydrochlorothiazide Tablets, USP Revised: February 2016 Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3008-3 | Lisinopril and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 68071-3008-6 | Lisinopril and hydrochlorothiazide | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 68071-3008-9 | Lisinopril and hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3008 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [NUCAREPHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240719_4fbf31a1-037b-31a2-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-3008-3 | 68071300803 | 30 TABLET in 1 BOTTLE (68071-3008-3) | 30 tablet | 2017-05-17 | 0000-00-00 | No | No | Current |
| 68071-3008-6 | 68071300806 | 60 TABLET in 1 BOTTLE (68071-3008-6) | 60 tablet | 2017-05-17 | 0000-00-00 | No | No | Current |
| 68071-3008-9 | 68071300809 | 90 TABLET in 1 BOTTLE (68071-3008-9) | 90 tablet | 2017-05-17 | 0000-00-00 | No | No | Current |