Propranolol Hydrochloride
- Product NDC
- 60760-538
- 11-digit product format
- 607600538
- Labeler code
- 60760
- Product ID
- 60760-538_9858fcb5-0a39-e175-e053-2a95a90a87d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propranolol hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- NDA018553
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2017-12-21
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 | 60760-538 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 60760-538 | 60760-538-30 | D | Discontinued by firm | 2026-08-17 |
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 | 60760-538-30 | 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 | 60760-538-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60760-538-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60760-538-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60760-538-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60760-538-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60760-538-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60760-538-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 60760-538-30 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018553-001 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 |
| N018553-002 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 |
| N018553-003 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 |
| N018553-004 | INDERAL LA | PROPRANOLOL HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018553-001 | AB |
| N018553-002 | AB |
| N018553-003 | AB |
| N018553-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-001 | INDERAL LA | 160MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-002 | INDERAL LA | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-003 | INDERAL LA | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1983-04-19 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-004 | INDERAL LA | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 1987-03-18 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018553-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018553-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018553-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018553-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018553-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018553-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018553-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018553-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018553-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018553-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018553-004 | AB | 1 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-538-30 | EA - Each | 60760-538 | 00202554-0353-4846-8e63-f00b84ada013 | 1 | 2020-01-03 |
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 ER | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 5415904b-90da-48e8-9f9e-f86749aa129c | 2024-08-01 | Warnings, Adverse reactions | 018553 NDA018553 |
| INDERAL LA | PROPRANOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 35d28979-36b1-4630-b85e-a44e0a443734 | 2024-08-01 | Warnings, Adverse reactions | 018553 NDA018553 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-538-30 | 60760053830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-538-30) | 2019-11-21 | 0000-00-00 | No | No | Current |