ELIXOPHYLLIN
- Product NDC
- 49708-644
- 11-digit product format
- 497080644
- Labeler code
- 49708
- Product ID
- 49708-644_bfd3f76e-094c-4148-a74b-f10efed03685
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THEOPHYLLINE ANHYDROUS
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Caraco Pharma, Inc.
- Application
- ANDA085186
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 80 mg/15mL
- Pharmacologic classes
- Methylxanthine [EPC],Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1d07c79-5983-427d-b6f5-df0550dcc598 | Product name | 4 | 20250325 |
| 7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2 | Product name | 1 | 20170302 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49708-644-90 | ML - Milliliter | 49708-644 | b14a1564-1240-4b2b-aa1f-33981852bfc9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ELIXOPHYLLIN (THEOPHYLLINE ANHYDROUS) LIQUID [ATLANTIC BIOLOGICALS CORPS] | 5 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 756226 | Elixophyllin 80 MG in 15 mL Elixir | PSN | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 313306 | theophylline 80 MG in 15 mL Oral Solution | PSN | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 756226 | theophylline 5.33 MG/ML Oral Solution [Elixophyllin] | SBD | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 313306 | theophylline 5.33 MG/ML Oral Solution | SCD | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 756226 | Elixophyllin 100 MG per 18.75 ML Elixir | SY | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 756226 | Elixophyllin 5.33 MG/ML Oral Solution | SY | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 756226 | Elixophyllin 80 MG per 15 ML Elixir | SY | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 313306 | theophylline 100 MG per 18.75 ML Oral Solution | SY | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |
| 313306 | theophylline 80 MG per 15 ML Oral Solution | SY | 7a5a367f-8461-4b15-99fc-f89aa7d5936e | 5 |