Home NDC 0781-2865-92 Ranitidine Hydrochloride
Product NDC 0781-2865
Requested package NDC 0781-2865-92
11-digit product format 007812865
Labeler code 0781
Product ID 0781-2865_ed4bcd49-22fa-4c8d-834a-4b6085889b4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application ANDA074655
Marketing category ANDA
Marketing start 1997-10-22
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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, 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…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A074655-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 A074655-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22
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 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074655-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1997-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074655-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB RS 1997-10-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 0781-2865-05 Ranitidine Hydrochloride 500 in 1 BOTTLE CAPSULE 500 23 0781-2865-31 Ranitidine Hydrochloride 30 in 1 BOTTLE CAPSULE 30 23 0781-2865-92 Ranitidine Hydrochloride 90 in 1 BOTTLE CAPSULE 90 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 AMMONIA INACTIVE INGREDIENT 5138Q19F1X RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 GELATIN INACTIVE INGREDIENT 2G86QN327L RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE HYDROCHLORIDE CAPSULE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC] 18 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-2865 RANITIDINE HYDROCHLORIDE CAPSULE [SANDOZ INC] 23 Legacy NDC, 3 package rows 20221130_b0af5ca1-9189-4c62-bdf1-f1124ec337e7.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 0781-2865-92 00781286592 90 CAPSULE in 1 BOTTLE (0781-2865-92) 90 capsule 1997-10-22 0000-00-00 No No Current