Isoflurane
- Product NDC
- 12164-012
- 11-digit product format
- 121640012
- Labeler code
- 12164
- Product ID
- 12164-012_c05e1421-6ea8-4037-b552-6ca4e5d992fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoflurane
- Dosage form
- LIQUID
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Halocarbon Life Sciences, LLC
- Application
- ANDA075225
- Marketing category
- ANDA
- Marketing start
- 1999-10-20
- Substance
- ISOFLURANE
- Active strength
- 1 mL/mL
- Pharmacologic classes
- General Anesthesia [PE], General Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isoflurane
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOFLURANE | 1 mL/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CYS9AKD70P |
| Rxcui | 542347 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 12164-012-10 | 2024-09-13 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-25 | 2024-09-13 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-10 | 2024-07-30 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-25 | 2024-07-30 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-10 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-25 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-10 | 2020-04-20 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-25 | 2020-04-20 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
| 12164-012-25 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ab7c-f424-e053-dadaa90a57ce | Isoflurane, USP Liquid For Inhalation |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12164-012-10 | Isoflurane | 100 mL in 1 BOTTLE, GLASS | LIQUID | 100 | | 4 |
| 12164-012-25 | Isoflurane | 250 mL in 1 BOTTLE, GLASS | LIQUID | 250 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12164-012 | ISOFLURANE LIQUID [HALOCARBON LIFE SCIENCES, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240915_e8e57cd7-b662-4e1c-beda-e73a4b3d16ae.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 |
|---|
| 12164-012-10 | 12164001210 | 100 mL in 1 BOTTLE, GLASS (12164-012-10) | 100 ml | 1999-10-20 | 0000-00-00 | No | No | Current |
| 12164-012-25 | 12164001225 | 250 mL in 1 BOTTLE, GLASS (12164-012-25) | 250 ml | 1999-10-20 | 0000-00-00 | No | No | Current |