propranolol hydrochloride
- Product NDC
- 72162-1605
- 11-digit product format
- 721621605
- Labeler code
- 72162
- Product ID
- 72162-1605_4265740f-b920-52c9-e063-6294a90a3ee4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propranolol hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078703
- Marketing category
- ANDA
- Marketing start
- 2013-03-11
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078703-001 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-002 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-003 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | |
| A078703-004 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078703-001 | AB |
| A078703-002 | AB |
| A078703-003 | AB |
| A078703-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-001 | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-002 | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-003 | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-004 | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2011-07-15 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078703-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078703-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078703-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078703-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078703-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078703-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078703-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078703-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078703-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078703-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078703-004 | AB | 1 | d06236e962d9… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e | 2026-07-08 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 14957737-4e53-cc6d-e063-6294a90a181e | 2026-06-29 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 36230aaa-b6e5-4ebb-e063-6294a90ac3b9 | 2026-06-25 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | AvKARE | 753ab3cb-e7ee-424b-aa7d-195b5871a40e | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | REMEDYREPACK INC. | e0241448-5727-4c68-ae2a-6f41cd962d7c | 2026-01-22 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa6 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 96fa108c-b31c-445c-b978-c848cac59419 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 2025-10-30 | Warnings, Adverse reactions | 078703 ANDA078703 72162-1605 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | e0959293-321d-4427-8bb7-8e74b03464d6 | 2025-10-13 | Warnings, Adverse reactions | 078703 ANDA078703 |
| Propranolol Hydrochloride | PROPRANOLOL HYDROCHLORIDE | American Health Packaging | 015b5e4f-3228-4259-b419-e0e49694a058 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 82a4d30b-5018-453d-a8ab-fef2e3266f69 | 2025-09-11 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | c5ad5449-b93e-4f26-977b-c66466d8ac6f | 2025-09-10 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | 179e31a7-9956-4fba-9e9a-2ca28d37d42b | 2025-08-04 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 5ee3776f-9d02-4d98-bc9d-e810c87961c3 | 2024-11-27 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 0e185e88-cea2-4d01-8711-67317247fd25 | 2024-10-04 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 44a7900c-b240-4e04-954e-2671d4d51ae7 | 2024-08-19 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Bryant Ranch Prepack | 8e675a00-2b20-4fcd-baa0-661bcf9809c8 | 2024-08-12 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | Proficient Rx LP | 1d7c1de3-3cf4-4b1e-bdcc-55f423c88001 | 2024-02-01 | Warnings, Adverse reactions | 078703 ANDA078703 |
| propranolol hydrochloride | PROPRANOLOL HYDROCHLORIDE | A-S Medication Solutions | d1cfdb57-0b04-43f7-bd10-c585f77385b3 | 2023-08-09 | Warnings, Adverse reactions | 078703 ANDA078703 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- propranolol hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROPRANOLOL HYDROCHLORIDE | 160 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F8A3652H1V | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 856481 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 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 |
|---|---|---|---|---|---|---|
| 72162-1605-1 | propranolol hydrochloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 102 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72162-1605-1 | EA - Each | 72162-1605 | dc25a78f-3794-4885-a07e-3d3b6d61c0f0 | 1 | 2023-12-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72162-1605 | PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20240415_5cf8d0a4-4e02-48f0-8d1f-564357b250c5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856481 | propranolol HCl 160 MG 24HR Extended Release Oral Capsule | PSN | 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 102 |
| 856481 | 24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule | SCD | 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 102 |
| 856481 | propranolol hydrochloride 160 MG 24 HR Extended Release Oral Capsule | SY | 5cf8d0a4-4e02-48f0-8d1f-564357b250c5 | 102 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72162-1605-1 | 72162160501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1605-1) | 2013-03-11 | No | No | Current |