Theophylline
- Product NDC
- 53808-0315
- 11-digit product format
- 538080315
- Labeler code
- 53808
- Product ID
- 53808-0315_adfc71f3-28e7-4f69-95bd-2f87e3c0243d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA089808
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 200 mg/1
- Pharmacologic classes
- Methylxanthine [EPC],Xanthines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0315-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c855-621f-e053-dbdaa90a74ad | Theophylline (Anhydrous) Extended-Release Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0315-1 | Theophylline(Anhydrous) | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0315 | THEOPHYLLINE (ANHYDROUS) (THEOPHYLLINE) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100809_fc61fd7e-63ca-4714-851f-31b2a045903d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 346574 | theophylline 200 MG Extended Release Oral Tablet | PSN | fc61fd7e-63ca-4714-851f-31b2a045903d | 1 |
| 317769 | theophylline 300 MG Extended Release Oral Tablet | PSN | fc61fd7e-63ca-4714-851f-31b2a045903d | 1 |
| 346574 | theophylline 200 MG Extended Release Oral Tablet | SCD | fc61fd7e-63ca-4714-851f-31b2a045903d | 1 |
| 317769 | theophylline 300 MG Extended Release Oral Tablet | SCD | fc61fd7e-63ca-4714-851f-31b2a045903d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0315-1 | 53808031501 | 30 in 1 BLISTER PACK | Historical |