Propranolol Hydrochloride
- Product NDC
- 51407-238
- 11-digit product format
- 514070238
- Labeler code
- 51407
- Product ID
- 51407-238_4f863b93-23da-bc07-e063-6394a90aed3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propranolol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA070213
- Marketing category
- ANDA
- Marketing start
- 1985-11-19
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 80 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 |
|---|---|---|---|---|---|---|---|
| A070213-001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | |
| A070213-002 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | |
| A070213-003 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | |
| A070213-004 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | |
| A070213-005 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070213-001 | AB |
| A070213-002 | AB |
| A070213-003 | AB |
| A070213-004 | AB |
| A070213-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-001 | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 1985-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-002 | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1985-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-003 | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1985-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-004 | PROPRANOLOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 1985-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-005 | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2011-04-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A070213-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A070213-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A070213-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A070213-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A070213-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A070213-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070213-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A070213-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070213-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070213-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070213-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070213-005 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Propranolol Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROPRANOLOL HYDROCHLORIDE | 80 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F8A3652H1V | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8cbac6dc-ef1d-6662-e053-2995a90af13f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cf | Product name | 2 | 20200609 |
| a5696e6c-a559-4d6b-bb53-f324106f317c | Product name | 1 | 20140718 |
| 0f446d3d-c9e6-1844-b8e8-a836dc35e0de | Product name | 1 | 20140508 |
| 33a4b7b4-a3c1-3f95-a202-01166dd77c44 | Product name | 1 | 20140508 |
| 60519d27-227d-404a-38bc-37524c8b386b | Product name | 1 | 20140508 |
| d5f30598-8f94-b083-f161-65d67f2ae12a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51407-238-01 | Propranolol Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 7 | |
| 51407-238-05 | Propranolol Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-238-01 | EA - Each | 51407-238 | a216674b-61a0-4e69-9207-fab32c338d11 | 1 | 2019-08-06 |
| 51407-238-05 | EA - Each | 51407-238 | 625fbcd2-b87a-4357-ae6d-09023f0c0955 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
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 | Golden State Medical Supply, Inc. | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 2026-04-15 | Warnings, Adverse reactions | 070213 ANDA070213 51407-238 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7da9bb37-cc22-4eff-8de0-429f64cb599e | 2026-01-22 | Warnings, Adverse reactions | 070213 ANDA070213 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | b94dcec7-7633-4a33-9cea-48161adeaf93 | 2026-01-15 | Warnings, Adverse reactions | 070213 ANDA070213 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3c05ab1f-05b0-494a-b640-667e7cf517a1 | 2021-07-01 | Warnings, Adverse reactions | 070213 ANDA070213 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856448 | propranolol HCl 10 MG Oral Tablet | PSN | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856457 | propranolol HCl 20 MG Oral Tablet | PSN | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856519 | propranolol HCl 40 MG Oral Tablet | PSN | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856556 | propranolol HCl 60 MG Oral Tablet | PSN | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856578 | propranolol HCl 80 MG Oral Tablet | PSN | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856448 | propranolol hydrochloride 10 MG Oral Tablet | SCD | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856457 | propranolol hydrochloride 20 MG Oral Tablet | SCD | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856519 | propranolol hydrochloride 40 MG Oral Tablet | SCD | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856556 | propranolol hydrochloride 60 MG Oral Tablet | SCD | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
| 856578 | propranolol hydrochloride 80 MG Oral Tablet | SCD | 8cbac6dc-ef1d-6662-e053-2995a90af13f | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51407-238-01 | 51407023801 | 100 TABLET in 1 BOTTLE, PLASTIC (51407-238-01) | 100 tablet | 2019-05-15 | 0000-00-00 | No | No | Current |
| 51407-238-05 | 51407023805 | 500 TABLET in 1 BOTTLE, PLASTIC (51407-238-05) | 500 tablet | 2019-05-15 | 0000-00-00 | No | No | Current |