Hydroxocobalamin
- Product NDC
- 0591-2888
- 11-digit product format
- 005912888
- Labeler code
- 0591
- Product ID
- 0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxocobalamin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA085998
- Marketing category
- ANDA
- Marketing start
- 2010-11-12
- Substance
- HYDROXOCOBALAMIN ACETATE
- Active strength
- 1000 ug/mL
- Pharmacologic classes
- Antidote [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxocobalamin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXOCOBALAMIN ACETATE | 1000 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S535M27N3Q |
| Rxcui | 317106 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2888-30 | Hydroxocobalamin | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | | 5 |
| 0591-2888-30 | Hydroxocobalamin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROXOCOBALAMIN ACETATE | ACTIVE INGREDIENT | S535M27N3Q | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| HYDROXOCOBALAMIN | ACTIVE MOIETY | Q40X8H422O | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| SODIUM ACETATE ANHYDROUS | INACTIVE INGREDIENT | NVG71ZZ7P0 | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2888 | HYDROXOCOBALAMIN INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240207_a3087a39-f218-4f16-a1e7-17c39bb2eb69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2888-30 | 00591288830 | 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE | 2010-11-12 | 0000-00-00 | No | No | Current |