Home NDC 0591-5556-10 Propranolol Hydrochloride
Product NDC 0591-5556
Requested package NDC 0591-5556-10
11-digit product format 005915556
Labeler code 0591
Product ID 0591-5556_c9eb1f85-2694-465e-9bca-17793419256c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA070177
Marketing category ANDA
Marketing start 1986-05-13
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 2020-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0591-5556 0591-5556-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0591-5556 0591-5556-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPRANOLOL HYDROCHLORIDE 40 mg/1
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.] 7 PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROPRANOLOL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5556 PROPRANOLOL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 14 Legacy NDC 20240517_ab9e5678-db53-4354-998a-ed8bf1d33e90.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 0591-5556-10 00591555610 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5556-10) 1000 tablet 1986-05-13 0000-00-00 No No Current