Theophylline
- Product NDC
- 42858-701
- 11-digit product format
- 428580701
- Labeler code
- 42858
- Product ID
- 42858-701_f343f33f-000b-42f5-a99f-a1cf52cecbce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals
- Application
- ANDA040086
- Marketing category
- ANDA
- Marketing start
- 2012-02-02
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 400 mg/1
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 2 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42858-701 | THEOPHYLLINE ANHYDROUS (THEOPHYLLINE) TABLET, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 8 | Legacy NDC | 20230919_bba266d2-1d22-49a9-b3db-e4f06802a8a9.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 |
|---|
| 42858-701-01 | 42858070101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01) | 2012-02-02 | 0000-00-00 | No | No | Current |