Home NDC 64679-907 RANITIDINE
Product NDC 64679-907
11-digit product format 646790907
Labeler code 64679
Product ID 64679-907_76bec459-49be-4132-843c-6f471dab81a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ranitidine
Dosage form TABLET
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA075208
Marketing category ANDA
Marketing start 1998-12-17
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 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 2 · 112 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075208-001 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 A075208-002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17
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 · 86 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 2026-09-14 22:38:34 2026-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 1998-12-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075208-001 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL AB 1998-12-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075208-002 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET / ORAL AB 1998-12-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-907-01 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-02 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-03 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-04 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-08 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-09 2024-11-06 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-01 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-02 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-03 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-04 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-08 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only 64679-907-09 2022-07-29 Ranitidine Tablets USP, 150 mg and 300 mg PRODUCT INFORMATION Rx Only
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [STAT RX USA LLC] 1 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM RANITIDINE TABLET [WOCKHARDT USA LLC] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [STAT RX USA LLC] 1 RANITIDINE ACTIVE MOIETY 884KT10YB7 RANITIDINE TABLET [WOCKHARDT USA LLC] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G RANITIDINE TABLET [STAT RX USA LLC] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G RANITIDINE TABLET [WOCKHARDT USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RANITIDINE TABLET [WOCKHARDT USA LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [WOCKHARDT USA LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RANITIDINE TABLET [STAT RX USA LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [STAT RX USA LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RANITIDINE TABLET [WOCKHARDT USA LLC] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [WOCKHARDT USA LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RANITIDINE TABLET [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [WOCKHARDT USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RANITIDINE TABLET [STAT RX USA LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RANITIDINE TABLET [STAT RX USA LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RANITIDINE TABLET [WOCKHARDT USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RANITIDINE TABLET [WOCKHARDT USA LLC] 1
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 64679-907-01 64679090701 30 TABLET in 1 BOTTLE (64679-907-01) 30 tablet 1998-12-17 0000-00-00 No No Current 64679-907-02 64679090702 250 TABLET in 1 BOTTLE (64679-907-02) 250 tablet 1998-12-17 0000-00-00 No No Current 64679-907-03 64679090703 10 BLISTER PACK in 1 CARTON (64679-907-03) > 10 TABLET in 1 BLISTER PACK 10 blister pack 1998-12-17 0000-00-00 No No Current 64679-907-04 64679090704 100 TABLET in 1 BOTTLE (64679-907-04) 100 tablet 1998-12-17 0000-00-00 No No Current 64679-907-08 64679090708 7500 TABLET in 1 DRUM (64679-907-08) 7500 tablet 1998-12-17 0000-00-00 No No Current 64679-907-09 64679090709 3750 TABLET in 1 DRUM (64679-907-09) 3750 tablet 1998-12-17 0000-00-00 No No Current