Home NDC 0115-1693 Propranolol Hydrochloride
Product NDC 0115-1693
11-digit product format 001151693
Labeler code 0115
Product ID 0115-1693_218a628d-de9d-4d32-943d-cb9cffa9515c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA071976
Marketing category ANDA
Marketing start 1990-09-30
Marketing end 0000-00-00
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 60 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 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 0115-1693-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0115-1693-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-1693-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-1693-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0115-1693-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0115-1693-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0115-1693-01 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071976-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 A071976-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL 1988-04-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL 1988-04-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL 1988-04-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB RS 1988-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071976-001 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL 1988-04-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A071976-002 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 1986-05-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 71 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-1693-01 Propranolol Hydrochloride 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1693 PROPRANOLOL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 5 Legacy NDC, 1 package rows 20201230_d71ac16a-e2df-4630-9653-28749ece80a2.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 · 2 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 0115-1693-01 00115169301 100 TABLET in 1 BOTTLE (0115-1693-01) 100 tablet 1990-09-30 0000-00-00 No No Current