Caffeine Citrate
- Product NDC
- 63323-407
- 11-digit product format
- 633230407
- Labeler code
- 63323
- Product ID
- 63323-407_2c3a55e5-1b61-4ed2-adca-c3beb44baf14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CAFFEINE CITRATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077997
- Marketing category
- ANDA
- Marketing start
- 2009-11-19
- Substance
- CAFFEINE CITRATE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Caffeine Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAFFEINE CITRATE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U26EO4675Q |
| Rxcui | 849931 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-407-03 | Caffeine Citrate | 3 mL in 1 VIAL | INJECTION, SOLUTION | 3 | | 10 |
| 63323-407-03 | Caffeine Citrate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 10 |
| 63323-407-04 | Caffeine Citrate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 5 |
| 63323-407-04 | Caffeine Citrate | 3 mL in 1 VIAL | INJECTION, SOLUTION | 3 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CAFFEINE CITRATE | ACTIVE INGREDIENT | U26EO4675Q | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| CAFFEINE CITRATE | ACTIVE INGREDIENT | U26EO4675Q | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-407 | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 10 | Current NDC, Legacy NDC, 2 package rows | 20230811_baf9f88a-776a-44e7-82cc-8f0ca419572f.zip |
| 63323-407 | CAFFEINE CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230720_38b39044-737a-4247-a6c4-c86f5e92490e.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 |
|---|
| 63323-407-03 | 63323040703 | 1 VIAL in 1 BOX (63323-407-03) / 3 mL in 1 VIAL | 1 vial | 2009-11-19 | 0000-00-00 | No | No | Current |
| 63323-407-04 | 63323040704 | 1 VIAL in 1 BOX (63323-407-04) / 3 mL in 1 VIAL | 1 vial | 2009-11-19 | 0000-00-00 | No | No | Current |