Edluar
- Product NDC
- 0037-6010
- 11-digit product format
- 000376010
- Labeler code
- 0037
- Product ID
- 0037-6010_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolpidem Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA021997
- Marketing category
- NDA
- Marketing start
- 2009-07-24
- Substance
- ZOLPIDEM TARTRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Edluar
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLPIDEM TARTRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WY6W63843K |
| Rxcui | 836641, 836645, 836647, 836649 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0037-6010-02 | 2021-10-01 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-02 | 2021-10-01 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-30 | 2021-10-01 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-30 | 2021-10-01 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-02 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-02 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-30 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
| 0037-6010-30 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1d37-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR ® (zolpidem tartrate) sublingual tablets, for oral use, CIV Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-6010-35 | Edluar | 6 in 1 BLISTER PACK | TABLET | 6 | | 22 |
| 0037-6010-93 | Edluar | 5 in 1 CARTON | TABLET | 5 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-6010 | EDLUAR (ZOLPIDEM TARTRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20221004_a32884d0-85b5-11de-8a39-0800200c9a66.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 |
|---|
| 0037-6010-02 | 00037601002 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) > 2 TABLET in 1 BLISTER PACK | 20 blister pack | 2009-07-24 | 0000-00-00 | No | No | Current |
| 0037-6010-30 | 00037601030 | 3 BLISTER PACK in 1 CARTON (0037-6010-30) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2009-07-24 | 0000-00-00 | No | No | Current |
| 0037-6010-35 | 00037601035 | 6 in 1 BLISTER PACK | | | | | | Historical |
| 0037-6010-93 | 00037601093 | 5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35) | 5 blister pack | 2022-07-20 | 0000-00-00 | No | No | Current |