Home NDC 53002-4950-0 Propranolol Hydrochloride
Product NDC 53002-4950
Requested package NDC 53002-4950-0
11-digit product format 530024950
Labeler code 53002
Product ID 53002-4950_138408f2-044e-4511-96da-2abb10500a0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA070177
Marketing category ANDA
Marketing start 2016-09-19
Marketing end 0000-00-00
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070177-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070177-001 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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table 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 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070177-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1986-05-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-4950-0 2025-01-30 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-3 2025-01-30 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-0 2023-06-08 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-3 2023-06-08 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-0 2023-01-30 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-3 2023-01-30 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-0 2020-12-15 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-3 2020-12-15 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-0 2020-01-31 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only 53002-4950-3 2020-01-31 Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-4950-0 Propranolol Hydrochloride 100 in 1 BOTTLE TABLET 100 9 53002-4950-3 Propranolol Hydrochloride 30 in 1 BOTTLE TABLET 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-4950 PROPRANOLOL HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.] 9 Legacy NDC, 2 package rows 20230609_5e05a9e2-289b-40d8-911a-d142ebf58882.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53002-4950-0 53002495000 100 TABLET in 1 BOTTLE (53002-4950-0) 100 tablet 2018-10-01 0000-00-00 No No Current