Propranolol Hydrochloride
- Product NDC
- 0904-6550
- 11-digit product format
- 009046550
- Labeler code
- 0904
- Product ID
- 0904-6550_887c75bb-6386-4fd8-bbee-f8f3dcd5f8c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propranolol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA070217
- Marketing category
- ANDA
- Marketing start
- 2010-06-21
- Marketing end
- 0000-00-00
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0904-6550 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 0904-6550 | 0904-6550-61 | D | Discontinued by firm | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-6550-61 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-6550-61 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6550-61 | EA - Each | 0904-6550 | 9b1b11d9-cab8-414c-8b99-88d9b4e866c9 | 1 | 2016-07-19 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | DIRECT RX | a834d1cf-72fc-93bf-e053-2995a90a6191 | 2025-01-17 | Warnings, Adverse reactions | 070217 ANDA070217 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 92c4bd8f-d0e6-d11a-e053-2995a90a635d | 2024-08-14 | Warnings, Adverse reactions | 070217 ANDA070217 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6550-61 | 00904655061 | 100 BLISTER PACK in 1 CARTON (0904-6550-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2010-06-21 | 0000-00-00 | No | No | Current |