Home NDC 0591-5554-10 Propranolol Hydrochloride
Product NDC 0591-5554
Requested package NDC 0591-5554-10
11-digit product format 005915554
Labeler code 0591
Product ID 0591-5554_c9eb1f85-2694-465e-9bca-17793419256c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA070175
Marketing category ANDA
Marketing start 1986-05-13
Marketing end 0000-00-00
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 10 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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 A070175-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG 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 A070175-001 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 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1986-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070175-001 PROPRANOLOL HYDROCHLORIDE 10MG 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 10 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 [BRYANT RANCH PREPACK] 1000 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1000 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 [CARILION MATERIALS MANAGEMENT] 4 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 4 PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) TABLET [STAT RX USA LLC] 1 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) TABLET [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5554 PROPRANOLOL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 14 Legacy NDC 20240517_ab9e5678-db53-4354-998a-ed8bf1d33e90.zip
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 0591-5554-10 00591555410 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5554-10) 1000 tablet 1986-05-13 0000-00-00 No No Current