Propafenone Hydrochloride
- Product NDC
- 0603-5449
- 11-digit product format
- 006035449
- Labeler code
- 0603
- Product ID
- 0603-5449_b375fca8-7731-4563-a237-2b066af75310
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propafenone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA075938
- Marketing category
- ANDA
- Marketing start
- 2002-10-17
- Marketing end
- 2024-04-30
- Substance
- PROPAFENONE HYDROCHLORIDE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 559c7edd-6d87-934f-8fcc-0cd5e9651949 | Product name | 7 | 20240226 |
| 06783798-d93a-d4be-8416-24bb30819d48 | Product name | 2 | 20160630 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0603-5449-21 | 2022-08-25 | C162847 | 48780-1 | e4f33bdf-aabf-d8a0-e053-dadaa90a6e4e | d4a552ce-f215-4ec7-b5dd-aee266ba9b08 |
| 0603-5449-25 | 2022-08-25 | C162847 | 48780-1 | e4f33bdf-aabf-d8a0-e053-dadaa90a6e4e | d4a552ce-f215-4ec7-b5dd-aee266ba9b08 |
| 0603-5449-21 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aabf-d8a0-e053-dadaa90a6e4e | d4a552ce-f215-4ec7-b5dd-aee266ba9b08 |
| 0603-5449-25 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aabf-d8a0-e053-dadaa90a6e4e | d4a552ce-f215-4ec7-b5dd-aee266ba9b08 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-5449-21 | EA - Each | 0603-5449 | 70bcca2a-94bb-46b6-babd-ce0d457afd45 | 1 | 2012-07-24 |
| 0603-5449-25 | EA - Each | 0603-5449 | 79c8560a-5ebc-4075-a546-20a7771e347f | 1 | 2013-02-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861427 | propafenone HCl 225 MG Oral Tablet | PSN | 5b3890cc-9078-4e11-b396-a26f75da3eb2 | 7 |
| 861427 | propafenone hydrochloride 225 MG Oral Tablet | SCD | 5b3890cc-9078-4e11-b396-a26f75da3eb2 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0603-5449-21 | 00603544921 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-21) | 2002-10-17 | 0000-00-00 | No | No | Current |
| 0603-5449-25 | 00603544925 | 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-25) | 2002-10-17 | 0000-00-00 | No | No | Current |