Home NDC 0378-0183 Propranolol Hydrochloride
Product NDC 0378-0183
11-digit product format 003780183
Labeler code 0378
Product ID 0378-0183_4b043e3b-c0dc-4e37-a2fb-86c51a99c054
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name propranolol hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA070213
Marketing category ANDA
Marketing start 1985-11-19
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070213-001 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 A070213-002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 A070213-003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 A070213-004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 A070213-005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 220 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 2026-10-15 13:18:30 2026-09 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-001 PROPRANOLOL HYDROCHLORIDE 40MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-002 PROPRANOLOL HYDROCHLORIDE 10MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-003 PROPRANOLOL HYDROCHLORIDE 20MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-004 PROPRANOLOL HYDROCHLORIDE 80MG TABLET / ORAL AB 1985-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070213-005 PROPRANOLOL HYDROCHLORIDE 60MG TABLET / ORAL AB 2011-04-08 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 6 · 220 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Propranolol Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPRANOLOL HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F8A3652H1V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856448 Internal RxNorm lookup 856457 Internal RxNorm lookup 856519 Internal RxNorm lookup 856556 Internal RxNorm lookup 856578 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-0183-01 Propranolol Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 13 0378-0183-10 Propranolol Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 PROPRANOLOL HYDROCHLORIDE ACTIVE INGREDIENT F8A3652H1V PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 PROPRANOLOL ACTIVE MOIETY 9Y8NXQ24VQ PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROPRANOLOL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0183 PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 2 package rows 20240420_b94dcec7-7633-4a33-9cea-48161adeaf93.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 · 4 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 0378-0183-01 00378018301 100 TABLET in 1 BOTTLE, PLASTIC (0378-0183-01) 100 tablet 1985-11-19 0000-00-00 No No Current 0378-0183-10 00378018310 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0183-10) 1000 tablet 1985-11-19 0000-00-00 No No Current