ORBIVAN
- Product NDC
- 59702-661
- 11-digit product format
- 597020661
- Labeler code
- 59702
- Product ID
- 59702-661_d3c69436-a681-4e00-8db0-8cbfaac9627e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Atley Pharmaceuticals, Inc.
- Application
- ANDA040885
- Marketing category
- ANDA
- Marketing start
- 2010-04-23
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 59702-661-01 | ORBIVAN | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 59702-661-12 | ORBIVAN | 1 in 1 POUCH | CAPSULE | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59702-661 | ORBIVAN (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ATLEY PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20100423_d3c69436-a681-4e00-8db0-8cbfaac9627e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 59702-661-01 | 59702066101 | 100 in 1 BOTTLE | Historical |
| 59702-661-12 | 59702066112 | 1 in 1 POUCH | Historical |