Theophylline
- Product NDC
- 63629-5198
- 11-digit product format
- 636295198
- Labeler code
- 63629
- Product ID
- 63629-5198_0a26ba42-6b96-467d-ab38-4b35988184f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089763
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- Pharmacologic classes
- Methylxanthine [EPC],Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-5198-1 | 2021-04-23 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
| 63629-5198-2 | 2021-04-23 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
| 63629-5198-3 | 2021-04-23 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
| 63629-5198-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
| 63629-5198-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
| 63629-5198-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e31a-f424-e053-dadaa90a57ce | e58491b5-b7de-4497-ab7a-d6c12972e744 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-5198-1 | EA - Each | 63629-5198 | c443a871-9f6e-49ee-ba3c-9e464a471dd2 | 1 | 2015-10-02 |
| 63629-5198-2 | EA - Each | 63629-5198 | 5ddd9ba0-f0b2-4e30-b592-4111e701d1b6 | 1 | 2015-10-02 |