Propranolol Hydrochloride
- Product NDC
- 55154-2584
- 11-digit product format
- 551542584
- Labeler code
- 55154
- Product ID
- 55154-2584_63abab85-ec88-4fcf-a8e7-0850e5f797ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Propranolol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078955
- Marketing category
- ANDA
- Marketing start
- 2026-07-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078955-001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | |
| A078955-002 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | |
| A078955-003 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | |
| A078955-004 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | |
| A078955-005 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078955-001 | AB |
| A078955-002 | AB |
| A078955-003 | AB |
| A078955-004 | AB |
| A078955-005 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-001 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-002 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2008-06-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-003 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2008-06-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-004 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-06-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-005 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2008-06-02 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078955-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078955-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078955-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078955-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078955-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078955-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078955-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078955-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078955-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078955-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078955-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078955-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078955-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078955-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078955-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078955-005 | AB | 1 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Propranolol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROPRANOLOL HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F8A3652H1V | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 856448 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 63abab85-ec88-4fcf-a8e7-0850e5f797ee | Available on FDA.report |
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 | American Health Packaging | c751ee54-27b4-4ed7-829a-ced735c41312 | 2026-09-02 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | 1bb6d65a-8264-4fa4-92d4-c4a756ec49ea | 2026-07-29 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Cardinal Health 107, LLC | 63abab85-ec88-4fcf-a8e7-0850e5f797ee | 2026-07-20 | Warnings, Adverse reactions | 078955 ANDA078955 55154-2584 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 554c7446-8407-460e-b157-f860c5afbf12 | 2026-07-14 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 54154f18-2f15-d247-e063-6294a90a7412 | 2026-06-12 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2c9a6403-5ebf-4348-be02-7ffad5832369 | 2026-06-10 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 4dd23053-0458-40f2-ac34-afb8cc9903aa | 2026-05-27 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol HCL | PROPRANOLOL HCL | Direct_Rx | 4ef5d75f-ca30-cd4a-e063-6394a90a8a43 | 2026-04-13 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | f70e5e97-a045-4d22-8da5-be4b7eb77530 | 2026-03-30 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 9390cfd6-b2e0-48ad-8c4d-ed63cf6b923a | 2026-03-19 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 8bdb15bc-5a25-4f20-af98-79bcd26022b8 | 2026-03-17 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8f31a40c-7c79-457b-af6e-d945e4807cff | 2026-03-13 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Coupler LLC | 4a006e05-b8c3-236c-e063-6294a90abf26 | 2026-02-04 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Ipca Laboratories Limited | 9288191e-4d07-4e37-ab66-7b9de9321cf3 | 2025-12-17 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Proficient Rx LP | e289160e-0f3a-4667-b8ba-9c93fbf21a30 | 2025-12-01 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | 62ef3d7d-c87f-4d2f-af12-47d50e8b5488 | 2025-08-08 | Warnings, Adverse reactions | 078955 ANDA078955 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | be55cf2d-c2f8-4781-b2ef-fd607324265c | 2025-08-08 | Warnings, Adverse reactions | 078955 ANDA078955 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55154-2584-0 | 55154258400 | 10 BLISTER PACK in 1 BAG (55154-2584-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2026-07-20 | No | No | Current |