Terrell
- Product NDC
- 66794-011
- 11-digit product format
- 667940011
- Labeler code
- 66794
- Product ID
- 66794-011_4f586e17-8aee-9567-e063-6294a90a1aa2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoflurane
- Dosage form
- LIQUID
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Piramal Critical Care, Inc.
- Application
- ANDA074416
- Marketing category
- ANDA
- Marketing start
- 2010-02-28
- Substance
- ISOFLURANE
- Active strength
- 1 mL/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terrell
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOFLURANE | 1 mL/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CYS9AKD70P |
| Rxcui | 542347, 542355 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66794-011-10 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-afd4-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 |
| 66794-011-25 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-afd4-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 |
| 66794-011-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afd4-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 |
| 66794-011-25 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afd4-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use TERRELL™(ISOFLURANE, USP) safely and effectively. See full prescribing information for TERRELL™(ISOFLURANE, USP). TERRELL™ (ISOFLURANE, USP)liquid for inhalation Initial U.S. Approval: 1979 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66794-011-10 | Terrell | 100 mL in 1 BOTTLE, GLASS | LIQUID | 100 | | 20 |
| 66794-011-25 | Terrell | 250 mL in 1 BOTTLE, GLASS | LIQUID | 250 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66794-011 | TERRELL (ISOFLURANE) LIQUID [PIRAMAL CRITICAL CARE INC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250214_dfb26527-c5ab-44d0-9236-24b1600e0db4.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 |
|---|
| 66794-011-10 | 66794001110 | 100 mL in 1 BOTTLE, GLASS (66794-011-10) | 100 ml | 2010-02-28 | 0000-00-00 | No | No | Current |
| 66794-011-25 | 66794001125 | 250 mL in 1 BOTTLE, GLASS (66794-011-25) | 250 ml | 2010-02-28 | 0000-00-00 | No | No | Current |