Home NDC 0781-1883 Ranitidine Hydrochloride
Product NDC 0781-1883
11-digit product format 007811883
Labeler code 0781
Product ID 0781-1883_b913def8-10c9-4651-82dc-a714decc1218
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ranitidine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA074467
Marketing category ANDA
Marketing start 1997-08-29
Marketing end 0000-00-00
Substance RANITIDINE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A074467-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 A074467-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29
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 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074467-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1997-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074467-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1997-08-29 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPSAICIN ACTIVE INGREDIENT S07O44R1ZM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CAPSAICIN ACTIVE MOIETY S07O44R1ZM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CETYL ACETATE INACTIVE INGREDIENT 4Q43814HXS INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PPG-20 METHYL GLUCOSE ETHER DISTEARATE INACTIVE INGREDIENT 0057334FAB INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 STEARETH-100 INACTIVE INGREDIENT 4OH5W9UM87 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 HYPROMELLOSE 2910 (3 CPS) INACTIVE INGREDIENT 0VUT3PMY82 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 HYPROMELLOSE 2910 (3 CPS) INACTIVE INGREDIENT 0VUT3PMY82 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings#